The development of an eHealth behaviour change intervention on reducing sedentary time in the secondary prevention of patients with coronary artery disease

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1 The development of an eHealth behaviour

change intervention on reducing sedentary

time in the secondary prevention of patients

with coronary artery disease

Nawa Azizi, Bsc.

1

_{Master Medical Informatics, Amsterdam University Medical Centers, location}

AMC, University of Amsterdam

T LESS

S

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Master Thesis

The development of an eHealth intervention on reducing sedentary time in the secondary

prevention of patients with coronary artery disease

Author

N. Azizi (Nawa), BSC.

Department of Medical Informatics, University of Amsterdam

Meibergdreef 9, 1105 AZ Amsterdam

Supervisor

Dr. F.P.J.M. Voorbraak (Frans)

Department of Medical Informatics, University of Amsterdam

Meibergdreef 9, 1105 AZ Amsterdam

Mentor

B. van Bakel (Bram), MSc.

Radboud UMC

Geert Grooteplein Zuid 10, 6525 GA Nijmegen

SRP Duration

December 2019 – July 2020

SRP Location

Radboud UMC

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Acknowledgements

This thesis is the last step in finishing my master Medical Informatics at the University of Amsterdam. The last few months I worked on my thesis at the Radboud University Medical Center in Nijmegen. This scientific research project was a great and educational journey. I developed such a broad understanding and gained in-depth knowledge in this interesting field of healthcare. Not only is this knowledge useful in healthcare, I am sure that I will use it in many other aspects in life.

There are a few people that I would like to thank in particular for making this possible. My daily supervisor Bram van Bakel has been a great mentor. Not only did he teach me how to perform proper research, but he also motivated me to improve myself. His guidance, support, patience and expert knowledge are exceptional.

I would like to thank my tutor Franks Voorbraak. He was my professor during the bachelor and the master and luckily, he also got to be my tutor during my final project. I would like to thank you for your guidance and skills, even in busy periods.

Last, I would like to thank my family and friends. In particular my parents and best friend. My parents who unconditionally supported me all these years; I would not have made it this far without you. My best friend Sara for always giving me advice and showing interest in my study; thank you for everything.

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Abstract

Introduction:

In 2016 ischemic heart diseases globally caused millions of deaths. Alongside traditional risk factors, physical activity (PA) is considered to be an important risk factor. However, patients surviving a cardiac event show little change in their PA. Recent research has associated prolonged sedentary time with an increased risk for cardiovascular diseases. Current cardiac rehabilitation (CR) programs and many eHealth interventions do not focus on reducing sedentary time amongst this highly sedentary population. Also, behaviour plays a key role in preventing and maintaining health. Thus, by targeting sedentary time by changing behaviour and by adding an eHealth component to current CR programs can be a promising addition to current CR programs.

Methods:

We followed the steps of the Intervention Mapping protocol in the development of the behaviour change intervention. We performed a needs assessment to identify what needs to be changed and for whom, in the form of a literature search. Second, we specified who and what will change as a result of the intervention. This starts with describing the end goal of the intervention, followed by defining performance and change objectives. The goal of the third step is to develop a coherent and practicable behaviour change intervention by selecting behaviour change techniques. The fourth step comprises the production of the intervention. It also includes pretesting and refining the intervention with the implementers and the recipients.

Results:

Most frequently found determinants were self-monitoring tools, personalised programs and counselling, lack of knowledge and goal setting. The goal of SIT LESS is to reduce sedentary time by 60 minutes per day. We defined five performance objectives to reach this end goal. First, we need to create awareness of the health effects of reducing sedentary time, followed by initiating a less sedentary lifestyle. Then, dealing effectively with triggers for sedentary behaviour is explained. Fourth, we explain how to use the Activ8 adequate as a self-monitoring device. Last, we provide the patients with weekly feedback on their progress that is registered by the Activ8, by a telephone consult. The program production resulted in four documents for the intervention that describe the content and delivery of the intervention. We were not able to evaluate the feasibility and acceptability of the intervention due to a global pandemic.

Discussion:

No international guidelines exist for sedentary time which makes it difficult to define cut-off points for the intervention. Fewer studies focus on sedentary behaviour since this is a relatively new in the research field. However, previous studies proved the effectiveness of a theoretical basis for an intervention. Also, the power of our study lies within the fact that we solely focus on reducing sedentary time.

Keywords – cardiac rehabilitation, behaviour change intervention, sedentary behaviour, eHealth, self-management

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Samenvatting

Introductie:

In 2016 veroorzaakten ischemische hartziekten wereldwijd miljoenen doden. Naast traditionele risicofactoren wordt lichamelijke activiteit (LA) als een belangrijke risicofactor beschouwd. Patiënten die een cardiovasculair event overleven, vertonen echter weinig verandering in hun LA. Uit recent onderzoek is gebleken dat een sedentaire leefstijl invloed heeft op een verhoogd risico op hart- en vaatziekten. De huidige programma's voor hartrevalidatie en veel eHealth interventies zijn niet gericht op het verminderen van zittijd onder deze zeer sedentaire populatie. Gedrag speelt ook een rol bij het voorkomen en behouden van gezondheid. Dus, het verminderen van zittijd door middel van een gedragsinterventie, bijgestaan door een eHealth-component als toevoeging aan huidige hartrevalidatie programma’s, kan een veelbelovende aanvulling zijn.

Methoden:

We hebben het Intervention Mapping protocol gevolgd bij de ontwikkeling van de gedragsveranderingsinterventie. We hebben een analyse uitgevoerd om te identificeren wat er veranderd moet worden en voor wie, in de vorm van een literatuuronderzoek. Ten tweede hebben we gespecificeerd wie en wat er zal veranderen als gevolg van de interventie. Dit begint met het beschrijven van het einddoel van de interventie, gevolgd door het definiëren van prestatie- en veranderingsdoelstellingen. Het doel van de derde stap is om een coherente en uitvoerbare gedragsveranderingsinterventie te ontwikkelen door gedragsveranderingstechnieken te selecteren. De vierde stap omvat de productie van de interventie. Het omvat ook het vooraf testen en verfijnen van de interventie met de zorgverleners en de hartpatiënten.

Resultaten:

De meest gevonden determinanten waren tools voor het monitoren van eigen gedrag, gepersonaliseerde programma's en begeleiding, gebrek aan kennis en het stellen van doelen. Het doel van SIT LESS is om de sedentaire tijd met 60 minuten per dag te verminderen. We hebben vijf prestatiedoelstellingen gedefinieerd om dit einddoel te bereiken. Ten eerste moeten we ons bewust worden van de gezondheidseffecten van het verminderen van sedentaire tijd, gevolgd door het initiëren van een minder sedentaire levensstijl. Vervolgens wordt de patiënt uitgelegd hoe effectief om te gaan met triggers voor sedentair gedrag. Ten vierde leggen we uit hoe de patiënt adequaat gebruik kan maken van Activ8 als monitoringtool. Tenslotte geven we de patiënten wekelijks feedback over hun voortgang die wordt geregistreerd door de Activ8, via een telefonisch consult. De programmaproductie resulteerde in vier documenten voor de interventie die de inhoud en uitvoering van de interventie omschrijven. Het was niet mogelijk om de interventie testen en verfijnen, en daarom de haalbaarheid en aanvaardbaarheid niet te evalueren.

Discussie:

Er bestaan geen internationale richtlijnen voor sedentaire tijd, wat het moeilijk maakt om afkappunten voor de interventie te definiëren. Er zijn minder studies gericht op sedentair gedrag, aangezien dit relatief nieuw is in het onderzoeksveld. Eerdere studies bewezen echter de effectiviteit van een theoretische basis voor een interventie. De kracht van ons onderzoek ligt ook in het feit dat we ons uitsluitend richten op het verminderen van sedentaire tijd.

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Steekwoorden - hartrevalidatie, gedragsverandering interventie, sedentair gedrag, eHealth, zelfmanagement

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1. Introduction

1.1 Introduction and Rationale

In 2016 ischemic heart diseases globally caused 9.4 million deaths[1], whereof 1.8 million deaths occurred in Europe[2]. Registry studies have found that 18 % of patients who suffered a myocardial infarction, suffer recurrent events within the first year[3]. It has been estimated that this could be more than halved if secondary prevention measures were more rigorously implemented [2] [4]. Alongside traditional risk factors such as smoking, hypertension and dyslipidaemia, physical activity is considered to be an important risk factor[5]. Physical activity (PA) is defined as any bodily movement produced by skeletal muscles that results in energy expenditure[1][2]. Research has shown that individuals who are more active have lower rates of all-cause mortality, including cardiovascular disease[8]. Yet, patients surviving a cardiac event show little change in their physical activity[9]. In contrast to physical activity, sedentary behaviour in terms of prolonged bouts of sitting time, has been associated with an increased risk for obesity, diabetes, cardiovascular diseases, and all-cause mortality[10][11][32]. Sedentary behaviour is any waking behaviour while in a sitting, reclining or lying posture [12]. Sedentary behaviour is not the same as physical inactivity, whereas sedentary behaviour is an independent behaviour and has its own health risks. Yet, no official or international guidelines or classifications are defined to classify a subject as sedentary [32].

Cardiac rehabilitation (CR) is a comprehensive multidisciplinary approach to care that is systematically applied and individually tailored to the needs of patients with cardiovascular disease (CVD)[13]. CR uses patient educations, health behaviour modification, and exercise training to improve secondary prevention outcome[14]. International clinical guidelines consistently identify exercise therapy as a central element of CR; exercise-based CR. Exercise-based CR programs are complemented with dietary counselling, stress management, medication and if needed guidance for smoking cessation. Although in the secondary prevention of cardiovascular disease exercise-based cardiac rehabilitation is well established[15], previous studies have found that after participating in an exercise-based cardiac rehabilitation program, sedentary time remains high[16][17]. Multiple studies evaluated the amount of physical activity that is needed to compensate for the detrimental health effects of sedentary behaviour, concluding that there is no straight forward answer and more research is needed[18][19]. Reducing sedentary is expected to have clinically relevant effects on the secondary prevention of CVD.

Many eHealth interventions in the secondary prevention of CVD focus on increasing physical activity from light intensity to moderate-or-vigorous intensity[20][21]. But systematic reviews and meta-analyses show that on average, interventions to support patients adherence to physical guidelines have small-to-medium effects that are not sustained over time and that the more effective interventions are complex and difficult to implement in routine care [22]–[25]. Few studies have evaluated why patients do or do not adhere to physical activity recommendations during traditional CR programs. Possible barriers in physical activity among patients are having a negative perceptions towards health and lifestyle changes, lacking knowledge and interest regarding physical activity and feeling physically restricted[26]–[28]. Hence, in the planning of physical activity interventions, it is essential to assess the patients’ view of specific barriers.

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Behaviour plays a key role in maintaining health, and in the prevention, management and treatment of disease and disability. Modification of behaviour is accomplished through systematic manipulation of the environmental and behavioural variables related to the specific behaviour to be changed[29][30]. Former research has shown that facilitators and barriers in achieving a healthy lifestyle after a cardiac event are mostly (perceived) behaviour factors. A big part of the patients do not have any trust in their own beliefs and are not ready or do not know how to change this lifestyle. Incorporating behaviour change techniques in current cardiac rehabilitation programs can improve the desired health effect of these programs. Behaviour change techniques (BCTs) are designed to enable behaviour change and can do this by augmenting factors that facilitate behaviour change or by mitigating factors that inhibit it. Thus, targeting sedentary time, accompanied by using behaviour change techniques, to current cardiac rehabilitation programs can be a promising additional component to contemporary programs. To research this gap, we developed an in-person delivered intervention integrated in routine care with an add-on eHealth component to prompt and monitor behaviour change. In this study we will investigate the effect of the ‘Sitting Interruption Treatment as a personalized Secondary prevention Strategy’ (SIT LESS) intervention on reducing sedentary time in patients with coronary artery disease by improving self-management, using behaviour change methods and including an eHealth monitoring device directly after CR.

1.2 Intervention Mapping: a theoretical approach for behaviour change interventions

Kok[31] describes three major challenges in planning behaviour change. First, the correct identification of the change objectives needs to be described, and thereby the evaluation outcomes. Second, appropriate behaviour change methods need to be selected and applied. Last, an adequate implementation of the intervention needs to be fulfilled. Kok also describes the use of the Intervention Mapping as a framework for successfully developing a behaviour change intervention. Hence, we decided to be guided by the steps of Intervention Mapping (IM) for the development of the SIT LESS intervention. IM is a planning approach that is based on using theory and evidence as foundations for taking an ecological approach to assessing and intervening in health problems[32]. The protocol of IM exists of six steps to get from problem identification to an intervention[33]. The six steps of the implementation of Intervention Mapping are described in Figure 1 and will be further explained in the following section.

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Figure 1. The six steps of the Intervention Mapping protocol

1.3 A practical example of a behaviour change intervention: AIMS

The Adherence Improving self-Management Strategy (AIMS) is developed for the care of Human Immunodeficiency Virus (HIV). The goal of the AIMS intervention is to enhance compliance of medication intake of HIV-patients. The intervention consists of structured modules with visual materials (1. Knowledge & Information; 2. Motivation; 3. Planning and self-efficacy; 4. Self-monitoring; 5. Learning & Problem Solving; 6. Maintenance of behaviour change), which are based on a thorough understanding of the barriers that drive medication adherence behaviour and potent behaviour change methods to modify those. AIMS consists of a series of 1-on-1 consults between patient and healthcare professional during regular outpatient clinic visits. The healthcare professional uses motivational speech techniques to inform the patient about the importance of a structured medicine intake and the health benefits that come along. Based on the patients’ perceived barriers, a personalised action plan with (weekly achievable) goals will be developed. The patient is monitored with an electronic pill box which registers medication intake every time the box is opened. Every 1-on-1 consult the action plan will be tailored based on output from the pill box, perceived barriers and together with the HCP, adequate solutions will be addressed.

Step 1 Logic Model of the Problem

•Conduct a needs assessment to create a logic model of the problem

•Describe the context for the intervention including the population, setting and community

•State program goals

Step 2 Logic Model of Change

•State expected outcomes for behavior and environment

•Specify performance objectives for behavioral and environmental outcomes •Select determinants for behavioral and

environmental outcomes

•Construct matrices of change objectives

Step 3 Program Design

•Generate program themes, components, scope and sequence •Choose theory- and evidence-based

change methods

•Select or design practical applications to deliver change methods

Step 4 Program Production

•Refine program structure and organization

•Prepare plans for program materials •Draft messages, materials and

protocols

•Pretest, refine and produce materials

Step 5 Program Implementation Plan

•Identify potential program users •State outcomes and performance

objectives for program use

•Construct matrices of change objectives for program use

•Design implementation interventions

Step 6 Evaluation Plan

•Write effect and process evaluation questions

•Develop indicators and measures for assessment

•Specify the evaluation design •Complete the evaluation plan

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AIMS has been evaluated in the context of HIV care to support medication adherence. AIMS is a feasible, acceptable and cost-effective behaviour change intervention delivered by trained nurses during routine clinical visits; and making use of electronic monitoring of behaviour to support behaviour change.

1.3 Research Aim

Adherence to a healthy lifestyle is important for the effectiveness and efficiency of many medical treatments. There is a lack of evidence on scalable and effective behavioural interventions to improve patient adherence to lifestyle recommendations in the treatment of coronary artery disease. The SIT LESS intervention is based on the Adherence Improving self-Management Strategy (AIMS). The overall aim of this thesis is to develop a feasible and acceptable behaviour change intervention to implement in the workflow of the healthcare providers. The main research question that will be answered in this thesis is:

“How can a feasible and acceptable behaviour change intervention in modifying sedentary behaviour be developed in the secondary prevention of ischemic heart disease, using an eHealth device?”

Scope of the Scientific Research Project

The SIT LESS intervention is a randomized clinical trial (RCT). My scientific research project (SRP) has a duration of seven months and will have an end goal other than the RCT. When we use the term end goal in the method- and results section, we refer to the end goal of the RCT. The framework of IM is based on the full process of development, implementation and evaluation of an intervention. The duration of my SRP allows us to execute 4 sections of IM, as this corresponds with the timeframe of my SRP. The SIT LESS intervention will be an addition to usual care by adding elements that focus on reducing sedentary time during the rehabilitation program. Appendix A provides a broader explanation of the SIT LESS study.

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2. Methods

2.1 Logic Model of the Problem

We conducted a needs assessment to create a logic model of the problem. In this first step the stakeholders, target group, experts, researchers and developers will investigate the problem.

Recommendations have been developed to address sedentary behaviour for certain adult populations[34], but none are specific to the unique profiles of cardiac rehabilitation patients. Therefore, we need to identify behavioural and environmental factors. It is important to identify the relation between the health problem, the behaviour and their environment. We will conduct a literature search on the determinants in reducing sedentary time and increasing physical activity. Based on the model by De Bruin and Hospers we will identify determinants that influence the intention on changing a behaviour[35].

2.1.1 Literature search

Search Strategy and Study Selection

We included studies based on four key research objectives: research related to the secondary prevention of CVD (1), identifying determinants (2) in sedentary behaviour and physical activity (3) in a qualitative design (4). To perform a comprehensive search of the available literature the electronic database of Ovid (Embase, Medline, PsycINFO) is accessed. Finally, one query is used for all sub-databases to extract articles (Table 1).

Table 1. Overview of all search terms.

Key Objective Search terms

Population ((cardiac rehab* or myocardial infarction or ST elevation myocardial infarction or non ST elevation myocardial infarction or acute coronary syndrome or ischemic heart disease or ischaemic heart disease or coronary artery disease)

AND

Behaviour (sedentary behavior or sedentary

behaviour or sedentary lifestyle or sedentary time or sitting time or sitting behaviour or sitting behavior or inactivity or inactive or inactive lifestyle)

AND

Intervention (determinant* or barrier* or facilitator* or facilitating factor or belief* or skill* or intention* or self-efficacy or attitude or risk perception or social influence or social norm)

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We applied our inclusion and exclusion criteria to all identified titles and abstracts to determine which articles should be advanced to the full-text review. We narrowed our search further by applying the following inclusion criteria:

• Addressed the cardiac population

• Addressed determinants in sedentary behaviour and/or physical activity • Addressed an intervention related to the cardiac population

• Published in English

If a study meets the criteria, they were exported to Rayyan for further screening[36]. To get a full grasp we included systematic reviews, narrative reviews, qualitive studies and quantitative studies. We excluded articles if the outcome, the population differed, or if there was no full-text available. Relevant articles were selected by the first reviewer (BVB) based on the inclusion and exclusion criteria.

2.1.2 Data Extraction

The data extraction methodology was guided by the behavioural model for medication adherence by De Bruin & Hospers[37]. We chose to use this model to create an in-depth understanding of all behaviour aspects of the problem. The behavioural model for medication adherence provides us with a framework of factors that influence behaviour (Figure 2). Based on the factors as described in the model, we developed a data extraction sheet and refined it throughout the process. Two researchers (BVB and NA) extracted data from the included articles and consulted with a third and fourth reviewer (JD and AJ) to achieve consensus on the final results of the data extraction.

The results from the literature search will be mapped as a logic model of the problem, according to the behavioural model of medication adherence, as described in figure 3. This will provide us a clear overview of the factors and their relations, and how they influence one’s intention on changing a behaviour.

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2.2 Program Outcome and Objectives – Logic Model of Change

The second step in IM is specifying who and what will change as a result of the intervention. This starts with describing the end goal of the intervention. Performance objectives are intermediate goals/steps that need to be undertaken to get to the end goal of the intervention. Performance objectives gives the patient a direction in which to grow to and to become the owner of the problem and solution. Change objectives are the behaviours that need to be changed in order to reach the end goal. Change objectives are gathered in the needs assessment and will also be assessed on their modifiability. For each performance objective we will identify change objectives and it will be documented in a matrix.

2.3 Program Design

The goal of the third step is to develop a coherent and practicable behaviour change intervention. Behaviour change techniques (BCTs) are designed to enable behaviour change, and can do this by augmenting factors that facilitate behaviour change or by mitigating factors that inhibit it. As an example, one might hypothesize that the BCT “Belief Selection” [33] (defined as: using messages designed to strengthen positive beliefs, weaken negative beliefs, and introduce new beliefs) might change behaviour on an individual level by increasing one’s belief in their ability in one’s skills/capabilities. On the other hand, the BCT “Planning coping responses” (defined as: getting the person to identify potential barriers and ways to overcome these) might change habitual behaviour by identifying high-risk situations and practice a coping-response.

By joint efforts of Barthomolew et al. a taxonomy of behaviour change methods for intervention mapping has been developed [33]. We will use the taxonomy to map relevant BCTs. Based on the matrix from step 2, we will identify the most suiting BCTs, describing how this BCT will be translated into a part of the intervention, including the parameters that need to be taken into account.

The result of step 3 will be generated program themes and components, and a matrix with the BCTs and their practical applications.

2.4 Program Production

The results from the previous steps function as a basis for the development. The fourth step comprises the production of the intervention. When finalizing the draft of the program materials, it is also required to pilot test the program materials with the intended implementers and recipients.

Design and approach

To pretest and refine the materials of the intervention we planned two focus groups. The first focus group will be with two HCPs and the second focus group will be with five cardiac patients. The HCPs are recruited by the main researcher (BvB) from the SIT LESS study. To prevent bias and to ensure double blinding, the selected HCPs for the focus group are also the only two HCPs whom will execute the intervention during the RCT. An interview guide is designed specifically for this study, with open-ended and close-open-ended questions per chapter of the materials to evaluate the correctness, completeness and feasibility of the materials. The feedback from the first group will be processed before proceeding to the second focus group.

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The patients for the second focus group are again recruited by the main researcher. This focus group will only evaluate the materials that are developed for the patients. We formulated open-ended and close-ended questions as a guidance and to develop new understandings of sedentary behaviour. The focus groups will be led by two researchers (BvB, NA) and two psychologists (JD, AJ). Both focus groups will be video-recorded and afterwards transcribed in Atlas.ti. After processing the feedback from the second focus group, we will finalize the program production. The products in Step 4 include a description of the scope and sequence of the components of the intervention, completed program materials, and program protocols.

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3. Results

3.1 Logic Model of the Problem

Our literature search yielded a total of 29 articles that aligned with our inclusion criteria (Figure 3). The included articles are reviews (n = 9), qualitative (n = 9) and quantitative (n = 9) research methods to examine barriers and facilitators in sedentary behaviour and physical activity. The remaining articles were book chapters (n = 2). We found a total of 70 determinants whom are mapped to 15 factors, whereof some determinants act as a barrier and as a facilitator. Because of the large number of determinants, we will only discuss the most common determinants. The complete overview can be found in the additional file.

Figure 3. Flow chart of study selection process. From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009)

Barriers and facilitators to reducing Sedentary Time and increasing Physical Activity

Sociodemographic characteristics.

Low socioeconomic status is mentioned [4], [26], [38]–[41] to be a barrier to physical activity. Neighbourhood wealth or deprivation influences the amount of physical activity people do. Depressive symptoms, anxiety or stressful events [4], [26], [34], [39], [42] causes cardiac patients to be less active. One participant summarized their feelings, saying "When I am feeling down, I can hardly even get myself out of bed, let alone do exercise" [26]. On the contrary, a subject’s psychological well-being leads to more physical activity[26], [41], [43].

Subjective norm.

Socially normative behaviour causes people to be more sedentary [34]. It is indicated that people experience social pressure to sit in certain situations, such as during a phone call, or during lunchbreak. Direct physician counseling, physician recommendations or a referral to a rehab program leads to an increase of physical activity [8], [26], [34], [38]–[40], [44], [45]. An older female heart-attack survivor said in an interview "I think it's important because my doctor has absolutely insisted and he was the one who got me started here and I'm still doing it three times a week"[38].

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Attitude.

Attitude is by far the most comprehensive factor of all, covering 15 determinants. Attitudes leading to less physical activity are a lack of interest [26], [27], [34], [40], [41], or a lack of motivation [26], [34], [38]. “If you could demonstrate me what would happen if I reduced my sitting time and what the health benefits were, that would motivate me” is a quote by a patient who questions the expected benefits of reducing sedentary time. But also having comorbidities leads to less physical activity [27], [34], [38], [41], [46]. It would affect one’s attitude thinking that because of a certain disability/comorbidity he/she can or will not perform physical activity. For example, a cardiac patient also having arthritis stated that “Arthritis is one reason I don’t exercise”[38]. The counterpart is experiencing pleasure and satisfaction [27], [44] from exercise causing patients to be physically more active. A patient’s belief, in our cases disbelief, in his/her ability to achieve health related goals leads an important role. If self-efficacy is low, it leads to less physical activity [26], [39], [40], [44], [46]–[48].

Facilitating factors.

Social support, group programs, emotional support from other cardiac patients[4], [26], [27], [38], [40], [44], [45], [48]–[50] and spousal support [4], [26], [27], [38], [46], [50], [51] is mentioned in many articles to be motivational for increasing physical activity. Particularly for men, the wife’s support can be very helpful; "Without my wife's support to exercise, there is no way I would've got to the level I am now"[26]. Also, the use of a physical activity monitoring devices is favorable. Providing a patient insight in their progress, encourages them to become more physically active to achieve certain goals[27], [34], [45], [46], [52]–[54]. A qualitative study exploring the acceptability of a pedometer found that using a pedometer is a powerful self-monitoring tool to create awareness of how sedentary one’s lifestyle was [52]. A 65-year old Caucasian verifies this by saying that “I really liked being able to see what I had done, and I can say, not exercising at all is a condition of extreme unconsciousness”. Individualized tailoring of programs and counselling [40], [52], [55] or interventions based on theoretical frameworks, tailored to individuals and delivered in a community based setting [56], increase the levels of physical activity. Last, health maintenance is a facilitating determinant [26], [27], [34], [38], [41]. A participant said in a qualitative study "I don’t want another stroke. I am willing to follow any advice that will make me healthy" [34].

Intrapersonal barriers.

Concerns about poor health, pain and poor functional capacity are intrapersonal determinants [26], [34], [38]–[40], [44], [57]. In a qualitative research a participant noted “My legs do not do what my mind wants to do” [28]. Complaints about not having the same energy levels or being in a lot of pain are barriers in reducing sedentary time and in increasing physical activity. As said in Rogerson, "You don’t have the same stamina and the same reserves within your body. Your energies are all totally depleted after heart surgery". Lack of time because of competing demands is also a reason why one is not able to increase physical activity [27], [28], [38], [44], [58]. In addition, work responsibilities are also considered an obstacle when it comes to being more active and less sedentary [28], [34], [38], [59](Ramirez, Traywick, Biswas, Fleury). They find it hard to incorporate breaks from sedentary time at work.

Environmental barriers.

Inclement weather [26]–[28], [38], [40], [57] and the distance to an exercise facility [28], [39], [40], [44], [59] are environmental barriers. Concluding that rainy weather and/or lack of transport would lead to less physical activity.

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3.2 Program Outcomes and Objectives; Logic Model of Change

3.2.1 Defining the end goal

The end goal of the SIT LESS study is:

To compare the effect of the 12-week SIT LESS intervention versus usual care on reducing sedentary time with 60 minutes per day in patients with coronary artery disease directly after cardiac rehabilitation.

3.2.2 Identifying modifiable determinants

A modifiable health determinant is described as a determinant that can be changed and as such it can be controlled to a certain extend[60]. Modifiable determinants are knowledge, skills, attitude, religion, employment, education, geographical location or access to health services[60]. Some of these modifiable determinants are out of the scope of our behaviour change intervention and will therefore not be included. The results can be found in table 2.

Factor Modifiable determinant

Subjective norm Direct physician counselling, socially normative behaviour

Attitude Lack of interest/questions about expected benefits, risk awareness, lack of

motivation, work responsibilities, acceptance of sedentary lifestyle, self-efficacy, feelings of embarrassment

Behavioural intention Lack of motivation

Self-regulatory processes Lack of will power/self-discipline, self-monitoring tools, goal setting

Facilitating factors Regular prompting and verbal persuasion, consistent provision of

information by health professionals, social support and spousal support, individualized tailoring of programs and counselling, find forms of reducing sitting time patients are likely to be adherent to, health maintenance, having an external reason for exercising

Intrapersonal barriers Physical condition/concerns about poor health, lack of time

Interpersonal barriers Lack of social support

Environmental barriers Home/working environment

Organizational barriers Time of activity

Cognitive and emotional evaluation past period

Regular monitoring of patient progress/feedback/follow-up, health provider contact/computer generated telephone reminders

Knowledge Lack of knowledge about exercise

Wrong assumptions Wrong assumptions

HCP-patient relationship Engaging with healthcare providers

Background variables None

Table 2. Modifiable determinants

3.2.3 Defining performance objectives and change objectives

Based on the results from the literature study, in combination with the study design from SIT LESS, we defined performance and change objectives. The first encounter between the HCP and the patient will be during the first consultation of the 12-week cardiac rehabilitation program. From this point until the last follow-up we described performance objectives (POs) and change objectives (COs) to change the patients’ behaviour.

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Performance objectives Change objectives Modifiable determinant

PO 1.

Create awareness of the health effects of reducing sedentary time

1.1 Inform about the health benefits of reducing sedentary time.

1.2 Validate with patient if he or she understands the information.

1.3 Validate with patient if they acknowledge the health benefits.

Understanding health

information, wrong assumptions, lack of knowledge, questions about expected benefits, risk awareness

PO 2. Initiate a less sedentary

lifestyle 2.1 Identify patients’ current lifestyle and sitting patterns.

2.2 Express the importance of reducing sedentary time.

2.3 Identify patients’ beliefs in reducing ST. 2.4 Confirm patients’ belief OR if they are inaccurate, correct their beliefs. Introduce new beliefs if needed.

2.5 Set a goal of the amount of reducing ST. Break down the goal in smaller weekly goals. 2.6 Express the confidence in their ability and knowledge in reducing ST.

Physical conditions, goal setting, find forms of reducing sitting time patients are likely to be adherent to, having an external reason for exercising, health maintenance

PO 3. Deal effectively with triggers for sedentary behaviour

3.1 Identify barriers in reducing ST

3.2 Express the commonality of their behaviour 3.3 Set up matching solutions for each barrier

Socially normative behaviour, lack of interest, feelings of embarrassment, Time of activity, distance to exercise facilities, lack of motivation, acceptance of sedentary lifestyle, work responsibilities, PO 4. Adequate use of activity

tracker as a self-monitoring device (increase self-efficacy)

4.1 Explain the use of the activity tracker (log-in, connection with computer, interpretation of the results).

4.2 Explain how the use of the Activ8 can support to achieve their goals.

4.3 Express the importance of wearing Activ8 to increase self-efficacy.

Regular monitoring of patient progress, feedback, computer generated telephone reminders, self-monitoring tools

PO 5. Weekly feedback on

progress 5.1 Identify how the patient thinks it went. 5.2 Provide feedback based on results from Activ8.

5.3 Identify possible problems.

5.4 Discuss possible solutions for the identified problems.

5.5 Emphasize what went well. Express confidence in adhering to the program.

5.6 Adjust, if needed, the weekly goals.

Regular prompting and verbal persuasion, consistent provision of information by health professionals, individualized tailoring of programs, engaging with healthcare providers

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21 3.3 Program Design

Program themes and components

As found in the literature search, verbal persuasion and personalized feedback are very helpful to convince the patient in their ability in changing their behaviour. We will develop materials for the HCPs that will train them in motivational speaking and in providing feedback. Another component that was found to be very helpful is a self-monitoring device. Therefore, the patient will wear the Activ8. The activity tracker consists of an inclinometer and a tri-axial accelerometer, which allows for recognizing prolonged periods of sedentary behaviour and physical activity patterns. Upon recording prolonged, uninterrupted sitting (i.e. 30 minutes), vibrotactile feedback will be provided by the activity tracker to remind patients to replace sedentary behaviour by low-intensity physical activity (e.g. standing or walking). Patients are able to review their sedentary behaviour and physical activity patterns in a web-based environment. From the modifiable determinants we also concluded that we will implement an information section about sedentary behaviour in the program of the intervention to increase knowledge and subsequently increase motivation in reducing sedentary time.

Matrix for behaviour change techniques

Table 4 shows the results of the mapping of the behaviour change techniques from Barthomolew et al. a taxonomy. Table 4: Matrix for POs, COs and their corresponding BCTs, parameters and practical applications

Performance objectives Change objectives BCTs Parameters Practical application How population, context and

parameters were taken into account

PO 1.

Create awareness of the health effects of reducing sedentary time

1.1 Inform about the health benefits of reducing sedentary time.

1.2 Validate with patient if he or she understands the information.

1.3 Validate with patient if they acknowledge the health benefits.

1.1 Consciousness raising Using Imagery 1.2 Active learning 1.3 Active learning

1.1 Can use feedback and confrontation; however, raising awareness must be quickly followed by increase in problem-solving ability and self-efficacy 1.1 Familiar physical or verbal images as analogies to a less familiar process 1.2 Time, information and skills

Provide the patient with reliable information regarding the health effects of

sedentary behaviour. Information will be

complemented with matching images to enhance awareness and to visualize the problem. This can be done by providing a spreadsheet or pamphlet.

Population: information is adjusted to the elderly population

Context: provide information about reducing ST in the context of CAD

Parameters: multiple images are developed to visualize the health effects of sedentary behaviour, accompanied by textual explanation of the health effects to increase the understanding of the health effect

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PO 2. Initiate a less

sedentary lifestyle 2.1 Identify patients’ current lifestyle and sitting

patterns.

2.2 Express the importance of reducing sedentary time. 2.3 Identify patients’ beliefs in reducing ST.

2.4 Confirm patients’ belief OR if they are inaccurate, correct their beliefs. Introduce new beliefs if needed.

2.5 Set a goal of the amount of reducing ST. Break down the goal in smaller weekly goals. 2.6 Express the confidence in their ability and knowledge in reducing ST. 2.1 Feedback on behaviour 2.2 Verbal persuasion 2.3 Goal setting 2.4 Feedback on behaviour 2.5 Belief selection, persuasive communication 2.6 Verbal persuasion 2.1 Feedback needs to be individual, follow the behaviour in time, and be specific.

2.2 Credible source 2.3 Commitment to the goal; goals that are difficult but available within the individual’s skill level 2.5 Requires investigation of the current attitudinal, normative and efficacy beliefs of the individual before choosing the beliefs on which to intervene 2.5 Messages need to be relevant and not too discrepant from the beliefs of the individual

The HCP must ask the patient what their daily sitting pattern is Discuss what the motivation is for reducing sedentary time. Identify the patients’ view on reducing sitting time. If the patient tells inaccurate beliefs, the healthcare provider will remove these beliefs. In collaboration with the HCP, the patient will setup a goal of the amount of time to reduce ST. They will develop an exercise plan to create structure in reducing ST.

Population: goals will be adjusted to elderly and sedentary population Context: HCP available for guidance of setting goal Parameters: the HCP will personalize the feedback and verbal persuasion based on patients’ reasons and concerns regarding reducing sedentary time, commitment of the goal is made by developing an exercise plan and planning a follow-up consultation

PO 3. Deal effectively with triggers for sedentary behaviour 3.1 Identify barriers in reducing ST 3.2 Express the commonality of their behaviour 3.3 Set up matching solutions for each barrier

3.1 Implementation intentions, stimulus control 3.2 Mobilizing social support, Facilitation 3.3 Planning coping response

3.1 Implementation: existing positive intention 3.1 Stimulus control: needs insight in the behavioural chain leading to the automatic response 3.2 Combines caring, trust, openness and acceptance with support for

behavioural change 3.2 Requires the identification of barriers

The patient will be asked to identify reasons or situations that conflict with the goal they have set. Also, they will be asked to look for possible solutions for each

threat/situation. They can be provided with a standard list of common problems and solutions to use. After identifying problems and solutions, they will write a coping plan.

Population: scenarios are presented that are applicable for cardiac patients

Context: HCP will help setup a coping plan and guide the patients in increasing self-confidence

Parameters: HCP will identify patients’ problem and provide them with possible solutions

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and facilitators and the power for making the appropriate changes 3.3 Identification of high-risk situations and practice coping response

PO 4. Adequate use of Activ8 as a self-monitoring device (increase self-efficacy)

4.1 Explain the use of the Activ8 (log-in, connection with computer,

interpretation of the results).

4.2 Explain how the use of the Activ8 can support to achieve their goals. 4.3 Express the importance of wearing Activ8 to increase self-efficacy.

Self-monitoring of behaviour Feedback

Feedback: Feedback needs to be individual, follow the behaviour in time, and be specific.

Self-monitoring of behaviour: the monitoring must be of the specific behaviour. The data must be interpreted and used. The reward must be reinforcing to the individual

The patient will be asked to wear the device for 12 weeks consecutive. The Activ8 is a self-monitoring device that will track all bodily

movements and can be worn in jeans. The Activ8 will detect when a subject is sitting for more than 30 minutes and will give a short vibrating signal to aware the patient of a prolonged sitting time.

Population: using simple terms to explain the use of Activ8 Context: showing the use in real life makes It easier to remind and understand Parameters: the output from the Activ8 is personalized and followed in time, it specifically monitors bodily movements and the data will be used and interpreted during

consultations PO 5. Weekly feedback on

progress by telephone coaching

5.1 Identify how the patient thinks it went. 5.2 Provide feedback based on results from Activ8. 5.3 Identify possible problems.

5.4 Discuss possible solutions for the identified problems.

5.5 Emphasize what went well. Express confidence in adhering to the program.

Motivational interviewing Facilitation

Goal setting Self-reevaluation Tailoring

Set graded tasks (PO 3, 4 and 5)

Self-reevaluation: stimulation of both cognitive and affective appraisal of self-image. Can use feedback and

confrontation; however raising awareness must be quickly followed by increase in problem-solving ability and self-efficacy Motivational interviewing: a supportive relationship between client and professional combined with the evocation of patient change talk.

Based on the information the Activ8 has collected, the healthcare provider will give weekly feedback/telephone coaching on the patients’ performance. Based on the feedback the goals can be adjusted. This will be supported by motivational speaking.

Population: considering this highly inactive population, weekly feedback will be provided to increase adherence

Context: telephone

consultations executed by the HCP

Parameters: the HCP and patient have an intense relationship as they will have weekly contact, during these weekly contacts feedback will be provided and the patient will evaluate their progress, based on the results from the Activ8, the HCP will tailorize the intervention, if its needed

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5.6 Adjust, if needed, the

weekly goals. Tailoring: tailoring variables or factors related

to behaviour change or to relevance

Set graded task: The final behaviour can be reduced to easier but increasingly difficult sub- behaviours.

the HCP will return to PO 3 and 4 to re-evaluate the COs

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25 3.4 Program production

Components of the intervention

The materials of the intervention finally resulted in multiple documents. As described in the study design of the SIT LESS intervention (see Appendix A), there are consecutive moments in the timeline of consultation and feedback. So, accordingly materials are developed. We developed content for the study materials for the patients including an instruction manual for the eHealth monitoring device, telephone coaching instructions for the HCPs, face-to-face counselling for the HCPs and evaluation questions for during the focus groups.

Summary of the intervention

Document 1: Materials SIT LESS intervention for the patient

Chapter 1. General explanation

A. Function of the heart

B. Treatment of coronary artery disease C. Medication

D. Cardiac rehabilitation E. Risk factors

Chapter 2. Explanation of the health effects of physical activity and sitting time

A. Image 1: health effects of high sitting time, including textual explanation

B. Image 2: health effects of physical activity, sitting time and steps per day, including textual explanation

C. Image 3: health risks and the amount of physical activity, including textual explanation

D. Image 4: relationship between health risks, physical activity and sitting time, including textual explanation

Chapter 3. Reasons and concerns about reducing sitting time A. A list of reasons to start reducing sitting time B. A list of concerns about reducing sitting time Chapter 4. Common problem and solutions about reducing sitting time

A. An overview of common problems and possible solutions Chapter 5: The activity tracker: Activ8

A. A manual of the use of the activity tracker with examples and screenshots of the output and how to interpret the output

Chapter 6: Telephone coaching

A. Information about the telephone coaching

Document 2: Instructions for telephone coaching for the HCP

This document contains a step by step instruction sheet of how to perform the telephone coaching consultation. Per step it also describes what needs to be discussed with the patient and how to formulate it. It accounts for multiple scenarios and can also be adjusted to the phase of rehabilitation they are in. Figure 4 gives a brief overview of the structure of the telephone coaching.

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Figure 4. Overview of the steps of the telephone coaching consultation

Document 3: Face-to-face counseling

During the 12-week program the patient has three face-to-face (F2F) consultations, whereas we developed three guides for the HCP for each consultation. We used the already existing instructions for the regular F2F counseling and extended them with elements of the SIT LESS study that are derived from the defined POs and COs. The materials of the F2F consultation are available on request.

Document 4: Interview guide for the focus groups

We developed evaluation questions which are based on the materials we developed in Document 1. Per chapter we set up evaluation questions that consists of a few open questions and a few closed questions. For example, the following questions are applicable for Chapter 1.

Step 1: Introduce goal and agenda of the consult

Step 2A:

The patient has adhered to the advice:

Empower it

Step 3A: Confirm the behavior that has led to adhering to the advice to enhance internal locus. Plan a

follow-up appointment

Step 2B:

The patient has not adhered to the advice: identify the obstacles

Step 3B: Motivational interviewing to find internal locus

Step 4A: Patient states that it cannot adhere to the program: repeat what the consequences for their health

outcomes and plan a follow-up appointment

Step 4B: Patient states that it going to try again to adhere to the program; search for scenarios where

the patient succeeded and build up from that. Plan a follow-up

appointment If the patient could not upload the

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1. Is the information applicable to the target group (patients with coronary artery disease)? 2. Is the information: a. Correct? b. Complete? c. Unnecessary? d. Relevant?

3. Is there a better alternative for this information or is it helpful?

4. The goal of this information is to let the patient realize that there are multiple risk factors for developing coronary artery disease and if you tackle multiple risk factors, the risk increases for a new health event. Do you have any ideas about this? Are the better alternatives about giving and presenting the information?

5. Are the icons clear? To they add any value to this chapter and to the information?

ID Stelling Totally

disagree

Disagree Neutral Agree Totally agree 1 In general I’m pleased with this

chapter of the materials.

2 The information in this chapter is understandable

3 If applicable: the images of this

chapter are visually attractive 4 If applicable: the images match with

the given information 6 This chapter contains all the

information that is needed

7 After reading the chapter, it is clear to me that:

- What coronary artery disease is

- What treatments are available - What the risk factors are 8 After reading this chapter I would give

the following suggestions/tips for improvement:

COVID-19

Due to a global pandemic, we were not able to execute the focus groups. As a team we searched for other options. Despite the efforts to investigate in other options to execute the focus groups, we were limited by the Medical Ethics Committee (METC). Since all METC applications for the SIT LESS study was already applied for and approved, we were legally not allowed to deviate from what is stated in the applications. Meaning that the research team must wait until they are allowed again to gather in real life for the focus groups.

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4. Discussion

The goal of this scientific research project is to investigate the feasibility and acceptability of a behaviour change intervention in the secondary prevention of coronary artery disease. It is part of the randomized clinical trial ‘Sitting interruption treatment as a personalized secondary prevention strategy in patients with coronary artery disease’ (SIT LESS). We implemented the steps of intervention mapping in the development of the SIT LESS intervention. We conducted a needs assessment in the form of a literature search, defined change and performance objectives to work towards the end goal, mapped the objectives to behaviour change techniques and their practical translation into the intervention, which resulted in the program production, whereof the final program would be tested during two focus groups with the recipients and implementers of the intervention. To assess the feasibility and acceptability of the intervention we predefined a minimum grade that should be scored during the focus groups.

Literature search

The aim of the literature search was to create a foundation for the behaviour change intervention. During the full text analysis, we filtered behavioural determinants from the articles. Our search yielded a total of 70 determinants that influence sedentary behaviour and physical activity, whereof the most common determinants are self-efficacy (n = 8, 27.6%), social support (n = 11, 37.9%) and direct physician counselling (n = 8, 27.6%). During the full text analysis, we noticed that not at all times the context was sufficient enough to allocate the found determinants to a section from the behaviour change model. To reinforce our decisions, we added quotes originating from the articles to our results. Finally, if the quotes were lacking, we debated which category of the behaviour change model was most suitable. After all, the emphasis was to find all determinants whereas the model functioned as a tool to categorize our findings. The more common determinants such as self-efficacy and monitoring tools are well known aspects and already covered in present studies or interventions. In our opinion, the greatest addition from our literature search are the findings of less common determinants. Determinants that occur less but can have a great impact are feelings of embarrassment, risk and fear (n = 2, 6.9%), acceptance of sedentary lifestyle (n = 1, 3.4%), socially normative behaviour (n = 1, 3.4%) and regular prompting and verbal persuasion (n = 2, 6.9%). If a patient thinks he/she is doing enough physical activity (“I get most of my exercise in housework and working in the yard”) or is making wrong assumptions (“Patients with high blood pressure should not do exercise”), then they will logically never become more active. These determinants should be considered to be adopted in current interventions for the secondary prevention of coronary artery disease. By creating awareness and by verifying the concept of sedentary behaviour amongst these highly inactive people, we think profit can be made. The data extraction methodology was guided by the behavioural model for medication adherence by De Bruin & Hospers (Figure 2). We chose to use this model to create an in-depth understanding of all behaviour aspects of the problem. The behavioural model for medication adherence provides us with a framework of factors that influence behaviour. What makes their model unique is the combination of various theories. It is based on the theory of planned behaviour, self-regulation theories and factors that determine adherence behaviour. The model is used in the care of HIV patients and has been proven to increase medical adherence. Previous studies using a single behavioural model or theory-based approach for an intervention for cardiac patients, practiced models such as the protection

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motivation theory (PMT)[20], social cognitive theory (SCT)[61], health belief model (HBM) [62] concluded that a single behavioural theory as base for an intervention, is more effective compared to usual care, but is more effective if more theories are used[63].

Intervention Mapping

We identified 5 performance objectives (POs) and each PO is supported by change objectives (COs). The POs and COs are linked to the modifiable determinants to ensure we covered all barriers and facilitators. The goal of each PO is to contribute to the desired health behaviour; in our case reducing daily sedentary time with 60 minutes. First, we need to create awareness of the health effects of sedentary behaviour. We used consciousness raising and active learning as the behaviour change techniques (BCTs) to accomplish the desired effect of the PO. After creating awareness, the next step is to initiate a less sedentary lifestyle. Dependant from the outcome of the initiation, the healthcare professional and patient will discuss how to deal effectively with triggers of sedentary behaviour. We used the results from the literature search as a framework for possible triggers and solutions. Also, we developed additional triggers and solutions based on common situations that may occur. Then, the use of the activity tracker will be explained. Instead of relying on self-reported data, we will track the patients with our advanced monitoring tool. We choose an eHealth solution in a web-based environment to gather accurate results. Last, the patient will receive weekly feedback by phone based on the results from the activity tracker. During these feedback moments, goals can be adjusted if they are not achieved. In total we used 18 different behaviour change techniques to construct our intervention. This may seem like a high number but a systematic review on 180 trials about reported changes in self-efficacy, found a significant positive relationship between the number of BCTs and effect sizes for maintained changes in self-efficacy for physical activity[64]. The most promising BCTs that were found in other interventions on sedentary behaviour are self-monitoring behaviour, problem solving and giving information on the health impact of sitting [36]. This corresponds to the BCTs we used in our intervention. The use of the IM protocol has been beneficial because the matrix forced us to think ahead of the practical applications of the BCTs.

Strengths

We adapted the approach whom also was used in the behaviour change intervention for Human immunodeficiency virus (HIV) patients to increase medication adherence. By understanding a patient’s motive on medication intake, based on these motives adopting and personalizing the intervention and last, providing feedback on their monitored behaviour, De Bruin was able to increase medication intake[65]. The importance of our study is to identify if the successful formula for their behaviour change intervention can be adapted to another field in medicine. Without standardized definitions of the techniques included in behaviour change interventions, it is difficult to faithfully replicate effective interventions and challenging to identify techniques contributing to effectiveness across interventions. Our contribution to current research is to identify what steps and which behaviour change techniques are the active ingredients. Since we systematically recorded all steps and were guided by the IM protocol, the evidence of which mechanisms caused effect can be traced. If our approach is proven to be effective, we contribute to scientific knowledge of behavioural science in the field of evidence-based health care.

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Although we are limited by the execution of our study, it is demonstrated that our study design is effective. A 2012 issue of Health Psychology Review provided examples of behaviour change interventions whom were effective, and they predicted that their effectiveness can be found in having a theoretical basis for an intervention [66]. These results emphasize the power of our study.

When providing regular feedback on a patients’ behaviour, we aim to also increase the patients’ self-efficacy. Self-efficacy refers to an individual’s belief in his or her capacity to execute behaviours necessary to produce specific performance attainments. If self-efficacy increases, the chances of a successful behaviour intervention also increase. The self-efficacy theory describes self-efficacy as the only determinant modelled as influencing all other variables, see Figure 5 [67]. The source of self-efficacy consists of four components and effects four aspects of human decision making. We covered three out of four components in our behaviour change intervention of which corresponds with the theory of self-efficacy; by pursuing verbal persuasion by the health care providers, by experiencing performance accomplishments during their own experiences, and by including model learning to build on vicarious experiences, we expect our intervention to be effective in changing patients’ behaviour.

Figure 5. Self-efficacy, its sources, and modes of induction (From: Bandura 1977, p. 195, and Reeve 2014, p. 277)

Limitations

In the context of sedentary behaviour, physical activity and the examination of determinants of these behaviours in cardiac patients, previous studies mainly focused on increasing physical activity. A limitation of our literature search is the shift of focus towards physical activity. Sedentary behaviour is a relatively new topic in the field of cardiology and less research has been done on this topic compared to physical activity. Since the arrival of wearables it has become more convenient to examine sedentary behaviour and the demand for studies investigating the effect of sedentary behaviour recently has been increasing[68].

On the present occasion, The World Health Organization still has no international guidelines regarding sedentary time[69]. Whereas for physical activity 150 minutes per week and 10000 steps per day is

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pursued to be healthy, no such cut-off values exist for sedentary time. This complicates the interpretation of the results in the context of public health.

We could not test the POs and COs with the implementers and recipients due to the current situation. Hence, we could not validate them and are they not foreseen with unexpected situations.

Prior to establishing the POs, COs and the materials, the study design for the SIT LESS intervention was fixed. Subsequently the development of the content took place. Therefore, there was little range in the construction of the intervention. However, it enabled us to work more goal-oriented instead of investing time and energy into manufacturing the intervention from scratch.

Due to Covid-19, we were limited in the execution of the focus group during the phase of Program Design. First, the healthcare professionals had other priorities during the pandemic. In the early stage of the development we planned a focus group for April with the nurses of the cardiac rehabilitation program. It was planned way ahead of time because most healthcare professionals have a busy schedule. However, when Covid-19 happened the priorities of the nurses changed, and they were much more needed in the healthcare. Besides shifted priorities of the nurses, we also informed the Patient Advisory Board for an online session of the focus group with the patients. Despite our best efforts to convince them of the importance of the focus group, they were not willing to cooperate. In contrary to what we found in other reviews, a 2010 study performed a analysis and meta-regression to research the impact of theory on the effectiveness of worksite physical activity interventions[70]. The study found that the effectiveness of BCTs is variable, and they do not have a full understanding of what accounts for this variability. This means that over a longer period of time, multiple studies need to validate if a certain BCT can be considered as effective. Also, reviews on behaviour change interventions used a retrospective method to discover which BCT has been used and can possibly be the active ingredient. However, during our study we recorded according to the IM protocol all employed BCTs and to what part of the intervention the BCT is connected. So, if the BCTs in our study do or do not contribute to the desired change in behaviour, it is also valuable information from our study that contributes to a better understanding of behaviour change.

Future research

Due to the absence of practical executions, future research should focus on the impact of the SIT LESS intervention on reducing sedentary behaviour. When proven to be effective, future research should also aim to investigate the generalizability of our study. First, by expanding to other non-communicable diseases whom can be affected by changing behaviour, with in the Radboud. Thereafter, the possibilities can be investigated for expanding international since ischemic heart diseases are a global problem. Future research should also focus on reaching consensus on defining international guidelines for sedentary behaviour. This can possibly be reached by investing more in time in researching sedentary behaviour.

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5. Conclusion

The results of this study yielded 29 articles and 70 determinants, whereof the determinants were divided into modifiable and non-modifiable. The modifiable determinants were translated into performance and change objectives, and finally mapped to behaviour change techniques. The end result is a package of four documents that describe the content and delivery of the SIT LESS intervention on reducing sedentary behaviour, supported by the Activ8 eHealth monitoring device. Altogether this study shows how to develop a behaviour change intervention, whom based on previous studies and literature, should be considered as feasible and acceptable.

The development of an eHealth behaviour change intervention on reducing sedentary time in the secondary prevention of patients with coronary artery disease

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