BSc Psychobiology
Bachelor project
19 / 06 / 2020
Screening and patient-tailored care for cognitive and emotional
problems decreases anxiety three months after ischemic stroke
Kim Soesbergen
11669403
Supervisors: Jos Slenders; Vincent Kwa Examinator: Harm Krugers
Screening and patient-tailored care for cognitive and emotional
problems decreases anxiety three months after ischemic stroke
Abstract
Background and Purpose. Ischemic stroke patients with good recovery in terms of physical impairments often recover at home. However, patients who are discharged home frequently experience emotional problems, such as symptoms of depression and/or anxiety. Today’s clinical measures capture these symptoms solely at a basic level which might result in these symptoms being missed, which could eventually cause social and economic problems. The effect of systematically screening for cognitive and emotional problems is currently unknown. The aim of this study is to determine the effects of screening and patient-tailored care for cognitive and emotional problems in patients discharged home after ischemic stroke, compared to obtaining care as usual.
Methods. Current research is part of the ECO-stroke trial, a multicenter, patient-blinded, cluster randomized controlled trial. The intervention consists of a 60-minute consultation, including screening and patient-tailored care for emotional and cognitive problems. Anxiety and depression symptoms are measured using the Hospital Anxiety and Depression Scale (HADS) at both six weeks and three months post-stroke. The HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) cut-off scores of eight were applied to explore effects of the intervention on clinical cut-off scores of symptoms of anxiety and depression.
Results. HADS-A scores of patients in the intervention group were significantly lower than those of patients in the control group at three months post-stroke. Within-subject comparisons showed that HADS-A scores of intervention patients had decreased at three months post-stroke compared to six weeks post-stroke. This was not the case in the control group. HADS-D scores showed no significant differences between control and intervention groups or between time measurements. Applying a HADS cut-off of eight to clinically assess clinical anxiety and depression did not show any effect of the intervention.
Conclusions. Systematically screening for emotional problems and cognitive problems reduces symptoms of anxiety but does not influence symptoms of depression within three months post-stroke.
Keywords: ischemic stroke; anxiety; depression; Hospital Anxiety and Depression Scale; screening; randomized controlled trial
Introduction
Strokes can be classified into hemorrhagic and ischemic strokes (Amarenco et al., 2009). During hemorrhagic stroke, an artery bursts and blood flows from the artery into the brain, whereas ischemic stroke occurs when an artery in the brain is obstructed and brain areas are retained from receiving blood (Zivin, 1998). A Transient Ischemic Attack (TIA) is similar to an ischemic stroke, but during a TIA, symptoms disappear within 24 hours (Zivin, 1998). Globally, stroke is the third most impacting disability measured in adjusted life years (Feigin et al., 2017). Ischemic strokes can be separated into severe strokes and minor strokes. This separation is based upon the patient’s impairments, which can be measured with the National Institutes of Health Stroke Scale (NIHSS). With this scale, neurological functions are assessed by measuring consciousness, vision, muscle strength, coordination, speech and other functions (Ortiz and Sacco, 2014).
After acute treatment, most stroke patients are first admitted to a stroke unit in the hospital, where patients are observed and treated until discharge. When needed, patients are given medications such as antihypertensives, anticoagulants and cholesterol lowering agents. After discharge from the hospital, several follow-up treatments regarding rehabilitation are possible. Depending on the patient’s needs, rehabilitation can consist of physiotherapy, occupational therapy, speech therapy, cognitive rehabilitation, psychotherapy, psychopharmacology and/or a consultation with the rehabilitation doctor (FederatieMedischSpecialisten, 2012). Usually, severe ischemic strokes are treated with inpatient rehabilitation treatment (Langhorne et al., 2011), whereas patients with minor strokes are mostly discharged home (Wade et al., 1984).
Besides physical problems, cognitive and emotional problems can occur after stroke, which are sometimes referred to as the invisible consequences of the stroke, as these symptoms are often not directly noticed. Cognitive impairment frequently occurs as a result of stroke (van Rooij et al., 2016, Edwards et al., 2013) and emotional problems occur in around 40% of minor stroke patients, depending on the time of measurement and the specific measurement used (Moran et al., 2014). Post-stroke emotional problems mostly include symptoms of anxiety and depression (Fure et al., 2006). Research with TIA and minor stroke patients showed that at one month post-stroke, 27% of the patients experienced anxiety symptoms and 20% of the patients showed symptoms of depression (Verbraak et al., 2012). Post-stroke depression is known to be most severe at six months to two years post-stroke (Parikh et al., 1989). Research into an outreach care program showed that if patients received three additional phone calls and a home visit, anxiety could be reduced (Boter,
depression within three months post-stroke, as measured with the Geriatric Depression Scale (Claiborne, 2006). Elderly patients sometimes feel uncomfortable labeling mental problems such as symptoms of depression. These patients often describe their symptoms of depression as “anxious” rather than “sad” (Gallo and Rabins, 1999), which may cause depression to be overlooked. Thus, as a result of ischemic stroke, patients, including those discharged home, often encounter cognitive and emotional problems. Symptoms of anxiety and depression have enormous effects on patients’ lives, as well as on society. For example, higher Hospital Anxiety and Depression Scale (HADS) scores, representing more severe anxiety and/or depression, were related to lower quality of life ratings in stroke patients (Minshall et al., 2020). Besides this, post-stroke anxiety and depression might withhold patients from resuming daily tasks (Muus et al., 2010, Kwa et al., 1996), which includes no or delayed return to work. This is known as a participation consequence since the patient experiences problems with participation in society due to the stroke. Eventually, this results in a social problem and high economic burden (Van Eeden et al., 2015).
Predictive factors of post-stroke anxiety include severity of the stroke, early anxiety, pre-stroke depression, and dementia or cognitive impairment post-pre-stroke (Menlove et al., 2015). Concerning post-stroke depression, predictive factors are found to be lower age, decreased physical functioning and lower Reintegration to Normal Living Index scores, which is a measurement to assess the ability to reintegrate into regular social activities after illness (Vermeer et al., 2018).
Symptoms of depression and anxiety can be measured using the HADS (Zigmond and Snaith, 1983), which was found to accurately identify symptoms at zero to six months post-stroke (Burton and Tyson, 2015). The HADS is a validated measurement for anxiety and depression in stroke patients (Turner et al., 2012, Sagen et al., 2009). The higher the HADS score, the more severe the anxiety and/or depression problems are. Earlier research with stroke patients showed mean scores of four out of 21 for both HADS-anxiety (HADS-A) and HADS-depression (HADS-D) (Broomfield et al., 2014). To clinically assess anxiety or depression, a cut-off score of eight or higher was found accurate for both HADS-A and HADS-D scores. This cut-off was determined by a receiver operating characteristic curve, based upon diagnosis of depression and anxiety guided by the Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases (Bjelland et al., 2002).
The above showed that symptoms of depression and anxiety occur frequently after stroke. According to the Dutch national stroke guideline, all patients should be screened for anxiety and depression after stroke (FederatieMedischSpecialisten, 2012). However, evidence of
screening for anxiety and depression being effective is limited and current usual care does not often include extensive screening for anxiety and depression (Bowen et al., 2005, Hart and Morris, 2008). As well as this, earlier research in England showed that stroke patients require better access to psychological support (Harrison et al., 2017). Thus, emotional problems in stroke patients may be missed, which could be the cause for decreased quality of life in later post-stroke stages (Baumann et al., 2014). The aim of this study is to determine the effects of screening and patient-tailored care for cognitive and emotional problems in patients discharged home after ischemic stroke, compared to care as usual. We hypothesized that within three months, depression and anxiety symptoms will decrease as a result of this intervention, compared to patients who receive care as usual.
Methods
Study Design
Current study is part of the Screening and patient-tailored care for Emotional and COgnitive problems in patients discharged home after ischemic stroke (ECO-stroke) trial. This trial is a multicenter, patient-blinded, cluster randomized controlled trial, registered in the Netherlands Trial Register (accessible at https://www.trialregister.nl/; registration number: NTR7504). The Medial research Ethics Committees United (MEC-U) in Nieuwegein has approved that the current study is not subject to the Medical Research Involving Human Subjects Act. Therefore, approval was given by the local medical ethics committees of all participating hospitals.
Trial Center Eligibility and Allocation
Hospitals were randomized according to a cluster randomization. Hospitals were considered eligible if no validated screening measurements for anxiety and depression are used systematically within three months after stroke, and if no long-term (more than six months) follow-up assessments are applied in the hospital’s current stroke care. In total, ten Dutch hospitals were determined as eligible trial centers. These hospitals were OLVG, Zuyderland location Heerlen, Tergooi, Ziekenhuis Amstelland, Het Van Weel-Bethesda Ziekenhuis, Maasstad Ziekenhuis, BovenIJ Ziekenhuis, Gelre Ziekenhuizen location Apeldoorn, Noordwest Ziekenhuisgroep location Alkmaar and Noordwest Ziekenhuisgroep location Den Helder. The eligible hospitals were cluster randomized in blocks of two according to a 1:1 ratio to the control group and the intervention group. The randomization was done using the web-based system Randomizer (Urbaniak, 2013).
Participants
Patients could be included in the study if the following criteria were met: ● aged above eighteen years;
● clinically diagnosed with ischemic stroke based upon history taking, neurological examination, and a computerized tomography (CT) scan or Magnetic Resonance Imaging (MRI)-brain scan;
● discharged home without follow-up treatment at rehabilitation outpatient clinics.
Patients who met the above-mentioned criteria were excluded from the study if the following exclusion criteria were met:
● a comorbidity which could interfere with outcome measures, is progressive, or has an associated life expectancy of less than six months;
● unable to complete questionnaires due to insufficient competence in the Dutch language or aphasia;
● legally incompetent; ● no informed consent.
Recruitment and Consent
At the time of hospital admission or during a visit to the outpatient clinic within four weeks after stroke, the patient’s health care professional asked the patient to participate in current research. If the patient agreed to participate, informed consent was signed.
Sample Size
For the ECO-stroke trial, a sample size calculation was performed which concluded that a total of 516 patients was needed. However, for current research this number was not achievable due to the limited duration of the internship. Therefore, the maximum achievable number of patients was considered acceptable.
Blinding
Patients were blinded for the treatment allocations, since they were not informed about the allocation of their hospital until after completion of the study. Clinicians and researchers were not blinded.
Control Group
Patients in the control group received care as usual only, which may differ depending on which hospital the patient was in. In general, stroke patients receive one appointment at the neurology outpatient clinic with a specialized nurse within three months post-stroke. During
this consultation, the diagnosis of ischemic stroke is explained, and vascular risk factors are discussed. As well as this, the use of medication is discussed.
Intervention Group
Patients in the intervention group received an outpatient follow-up with a specialized nurse at the hospital’s stroke aftercare clinic within six weeks post-stroke. This 60-minute consultation included specific screening instruments and therefore took longer than the control consultation. These instruments included the Checklist for Cognitive and Emotional consequences following stroke (CLCE-24), which is a list of 24 questions assessing the presence of cognitive and emotional problems (Van Heugten et al., 2007). Besides this, the Montreal Cognitive Assessment (MoCA) was used to assess post-stroke cognitive impairment (Cumming et al., 2013). Furthermore, the Restriction subscale of the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-Participation-R) assessed subjective restrictions in participation (Post et al., 2012). The HADS was used to screen for symptoms of anxiety and depression. In addition to this, the patient’s coping ability in daily living was assessed with the General Self-Efficacy Scale (GSES) (Sherer et al., 1982). A decision tool, based on results of the screening, was used for referral to rehabilitation services. This decision tool advised to refer patients to rehabilitation services if one or more participation restrictions on the GSES were found. To optimize follow-up care, close cooperation with the physiatrist was advised. The above-mentioned measures were additional to usual care.
Study Procedure
In both the intervention group and in the control group, most medical and demographic characteristics were obtained at baseline within six weeks post-stroke. The remaining demographics, level of education and relationship status, were obtained in the first questionnaire at six weeks post-stroke. Patients in both groups received a questionnaire at six weeks and three months post-stroke. Both questionnaires included the HADS. Patients in the intervention group received the intervention consultation with additional care at six weeks, whereas control group patients received the care as usual consultation (see Fig. 1). In the intervention group, the first HADS questionnaire was filled-in on paper and brought to the consultation. In the control group, the first questionnaire was filled in on paper and send by post, or filled in online, depending on the patient’s preference. The second HADS questionnaire was filled in either online or on paper, depending on the patient’s preference. In case of delayed responses, patients were contacted by phone. All data was pseudonymized and saved in the online database Castor EDC (Castor, 2019).
Figure 1 A schematic overview of the procedure for both the intervention and control group.
Eligible hospitals are allocated to either the intervention or the control group. Patients are screened. Control group patients receive a regular consultation and intervention group patients receive the intervention consultation at six weeks post stroke. Both the intervention and control group patients receive a HADS questionnaire at six weeks and three months post stroke.
Demographic Characteristic
The following demographic and medical characteristics were obtained: age, sex, use of antidepressant, infarction location, NIHSS score, relationship status and level of education. Level of education was divided into high education and low education, in which high education represented university or college education and low education represented all other forms of education.
Outcome Measures
Emotional problems were measured using the HADS (see Appendix). The HADS consists of two domains which are the HADS-A and HADS-D domains. Each domain consists of seven questions and each answer to a question corresponds to a score of zero to three. By calculating the sum of these scores, the total HADS-A and HADS-D scores, ranging from zero to 21, were determined for both anxiety and depression separately. The higher the score, the more severe the symptoms of anxiety or depression.
To test for differences in occurrence of serious anxiety and depression between control and intervention group patients, a HADS-A and HADS-D cut-off of eight was applied, wherein HADS-A and HADS-D scores of eight or higher were considered as significant anxiety and/or depression problems.
Statistical Analysis
Statistical analyses were performed using the program Statistical Package for the Social Sciences, Version 21 (IBM, 2012). Patients were included in current analyses only if both the first and the second HADS questionnaires were present.
The demographic and medical characteristics including sex, relationship status, level of education, infarction location and use of antidepressants of the control and intervention groups were compared using a Pearson Chi Square test. Age and NIHSS scores were compared using an independent t-test if assumptions were met. Levene’s tests were used to check the assumption of equal variances and Shapiro-Wilk tests were used to check for normal distributions. If these assumptions were not met, a Mann-Whitney U test was performed instead.
In order to decide whether the HADS-A and HADS-D scores of control and intervention groups showed a difference before the intervention, the HADS-A and HADS-D scores of the control group at six weeks post-stroke were compared to the HADS-A and HADS-D scores of the intervention group at six weeks post-stroke. For this, an independent t-test was performed if the assumptions were met. If assumptions were not met, a Mann-Whitney U test was used. Consequently, the HADS-A and HADS-D scores of the control and intervention groups at three months post-stroke were compared. Again, if assumptions were met, an independent t-test was performed and if not, a Mann-Whitney U test was performed.
To determine whether anxiety and depression symptoms differed within subjects, the HADS scores of each patient at six weeks post-stroke were compared to the HADS scores of the same patient at three months post-stroke. If the assumptions of equal variances and normal distributions were met, a dependent t-test was performed. If the assumptions were not met, a Wilcoxon Matched-Pairs test was performed. This was done for both the HADS-A as the HADS-D scores of each included patient.
As well as this, the following steps were taken to determine whether control and intervention groups differed in anxiety and depression problems when applying the cut-off of eight for the HADS-A and HADS-D scores. The HADS-A and HADS-D scores were dichotomized wherein scores of eight and higher were considered as anxiety and depression, respectively. Scores below eight were considered as an absence of anxiety and depression. A Chi-squared test was performed wherein the number of patients scoring above cut-off in the control and intervention group were compared at both six weeks and three months post-stroke. This was done for both anxiety and depression. In addition to this, the number of patients scoring above cut-off at six weeks post-stroke was compared to the number of patients scoring above cut-off at three months post-stroke. This was done for both HADS-A and HADS-D and both the control and intervention groups.
Results
Between August 2019 and April 2020, 78 patients were included in the ECO-stroke trial. Of the control group, three patients were lost to follow-up and four patients had not completed both questionnaires. In the intervention group, one patient was lost to follow-up and ten patients did not complete both questionnaires. Thus, a total of 60 patients were included in the analyses of current paper. The control group consisted of 22 patients and the intervention group of 38 patients (see Fig. 2). Of all patients, 21 (35%) completed one or both the questionnaires during the SARS-CoV-2 outbreak.
Figure 2 Flowchart of hospital allocation and patient inclusion. Number of patients lost to
follow-up and number of patients with incomplete questionnaires are illustrated.
Table 1 shows the demographic and medical characteristics of all patients, and the patients in the control group and intervention group separately. Of all patients, most were male (n = 33; 55%). Mean age was 73.1 ± 9.9. Ischemic stroke occurred most frequently in the territory of the a. cerebri media (n = 31; 52%), then in vertebrobasilar regions (n = 23; 38%) and then in the a. cerebri posterior (n = 4; 7%). Four patients (7%) showed ischemic strokes with an unknown location. The mean NIHSS score was 2.3 ± 2.7. Of all patients, five (8%) used one or more antidepressants at the time of inclusion. Of two patients (3%) the use of antidepressants was unknown. The level of education was high for sixteen patients (27%). Of all patients, 42 (70%) had a partner at the time of inclusion. The Pearson Chi-Square and Mann-Whitney U tests showed that none of the demographic and medical characteristics differed significantly between the control and intervention group.
Table 1 Baseline characteristics
All
(n = 60) Control group (n = 22) Intervention group (n = 38) p-value Sex n (%) female 27 (45) 8 (26) 19 (50) 0.306 Age (mean ± SD) 73.1 ± 9.9 70.4 ± 9.4 75.6 ± 10.0 0.079 Stroke location n (%) a. cerebri media n (%) a. cerebri posterior n (%) a. vertebrobasilar n (%) unclear 31 (52) 4 (7) 23 (38) 4 (7) 14 (64) 0 (0) 6 (27) 2 (9) 17 (45) 2 (5) 17 (45) 2 (5) 0.316 NIHSS (mean ± SD) 2.3 ± 2.7 1.9 ± 2.9 2.5 ± 2.6 0.128 Antidepressant use n (%) positive n (%) unknown 5 (8) 2 (3) 1 (5) 2 (9) 4 (11) 0 (0) 0.131 Level of education n (%) high 16 (27) 3 (14) 13 (34) 0.147 Partner n (%) positive 42 (70) 17 (77) 25 (66) 0.350
NIHSS indicates National Institutes of Health Stroke Scale; SD indicates standard deviation Table 2 summarizes HADS-A and HADS-D scores for both the control and intervention groups at six weeks and three months post-stroke. The Mann-Whitney U test showed no statistical difference in HADS-A scores between the control (5.3 ± 3.4) and intervention group (4.4 ± 4.0) at six weeks post-stroke (p = 0.187). The HADS-D scores for the control (3.5 ± 2.8) and intervention (3.8 ± 3.6) group at six weeks were equal as well (p = 0.988). Concerning the scores at three months post stroke, HADS-A scores of control group patients (5.6 ± 4.6) were significantly higher (p = 0.046) compared to the scores of intervention group patients (3.3 ± 3.9). The HADS-D control group scores (4.2 ± 4.2) at three months post stroke were not statistically different (p = 0.739) from the intervention group scores (3.8 ± 4.1). These results are displayed in Figures 3 and 4.
Table 2 HADS-A and HADS-D scores at six weeks and three months post-stroke Control group (n = 22) Intervention group (n = 38) p-value HADS-A (mean ± SD) 6 weeks 3 months 5.3 ± 3.4 5.6 ± 4.6 4.4 ± 4.0 3.3 ± 3.9 0.187 0.046 HADS-D (mean ± SD) 6 weeks 3 months 3.5 ± 2.8 4.2 ± 4.2 3.8 ± 3.6 3.8 ± 4.1 0.988 0.739
HADS-A indicates Hospital Anxiety and Depression Scale-Anxiety; HADS-D indicates Hospital Anxiety and Depression Scale-Depression; SD indicates standard deviation
A Wilcoxon matched pairs test showed that patients in the intervention group showed significantly lower HADS-A scores at three months than six weeks post-stroke (p = 0.024). A paired t-test showed no significant within-subject difference in the control group (p = 0.642) (see Fig. 3). The HADS-D scores showed no differences between six weeks and three months post-stroke for both the control group (p = 0.740) and intervention group (p = 0.836) (see Fig. 4).
Figure 3 A boxplot of the HADS-A scores of control group and intervention group at six
weeks and three months post-stroke. Dots indicate mild outliers (> Q3 - 1.5 * IQR) and the cross indicates an extreme outlier (> Q3 + 3 * IQR). The asterisks indicate a significant difference (p < 0.05).
Figure 4 A boxplot of the HADS-D scores of control group and intervention group at six
weeks and three months post-stroke.
Consequently, the cut-off score of eight for both the HADS-A and the HADS-D was taken into account and summarized in Table 3. The between-subjects analyses showed that, at six weeks post-stroke, the number of patients scoring above HADS-A and HADS-D cut-off in control (32% and 5%, respectively) and intervention group (18% and 18%) did not differ significantly (p = 0.237 and p = 0.128, respectively). At three months post-stroke, the number of patients scoring above HADS-A cut-off was higher in the control (32%) than intervention group (13%) but this did not differ significantly (p = 0.082) (see Fig. 5). Considering the HADS-D scores, the number of patients in the control group (23%) and intervention group (18%) showed no significant difference (p = 0.688) at three months post-stroke (see Fig. 6).
Table 3 Percentages of patients scoring above the HADS-A and HADS-D cut-off at six
weeks and three months post-stroke
Control group (n = 22) Intervention group (n = 38) p-value % HADS-A ≥8 cut-off 6 weeks 3 months 32 32 18 13 0.237 0.082 % HADS-D ≥8 cut-off 6 weeks 3 months 5 23 18 18 0.128 0.688
HADS-A indicates Hospital Anxiety and Depression Scale-Anxiety; HADS-D indicates Hospital Anxiety and Depression Scale-Depression; SD indicates standard deviation
As well as this, a within-subjects design was performed to compare the number of patients scoring above cut-off at six weeks to the number of patients scoring above cut-off at three months. The number of patients in the control group scoring above HADS-A cut-off at six weeks post-stroke and three months post-stroke did not differ (p = 1.000). The intervention group did also not show a significant difference in the number of people scoring above HADS-A cut-off at six weeks and three months post-stroke (p = 0.744) (see Fig. 5). The number of patients in the control group scoring above HADS-D cut-off was higher at three months post-stroke compared to six weeks post-stroke, but this difference was not significant (p = 0.079). In the intervention group, the number of patients scoring above HADS-D cut-off was the same at six weeks and three months post-stroke (p = 1.000) (see Fig. 6).
Figure 5 A bar chart showing the percentages of patients in the control and intervention
groups scoring above HADS-A cut-off at six weeks and three months post-stroke.
Figure 6 A bar chart showing the percentages of patients in the control and intervention
Discussion
This study examined the effects of screening and patient-tailored care for emotional problems and cognitive problems on symptoms of anxiety and depression within three months after ischemic stroke. Results showed that the screening intervention reduced symptoms of anxiety within three months post-stroke. Symptoms of depression were not influenced as a result of the screening intervention. Applying a cut-off of eight on the HADS-A and HHADS-ADS-D to clinically assess problems of anxiety and depression showed that the intervention did not influence anxiety and depression as defined by this cut-off.
Mean HADS-A and HADS-D scores in current research were comparable to those in earlier research with stroke patients. Current research showed mean HADS-A scores at six weeks post-stroke to be 5.3 ± 3.4 and 4.4 ± 4.0 for control and intervention group patients, respectively. In earlier research, the mean HADS-A score in stroke patients was four (Broomfield et al., 2014). Concerning the HADS-D scores, current research showed mean scores of 3.5 ± 2.8 and 3.8 ± 3.6 for control and intervention group patients, respectively. Here, earlier research showed a mean HADS-D of four (Broomfield et al., 2014), which is comparable to current results. Therefore, it is plausible that HADS-A and HADS-D scores were measured accurately. Earlier research showed that one month after minor stroke, symptoms of anxiety occur more frequently than symptoms of depression (27% vs 20%) (Verbraak et al., 2012). Similarly, current research showed a higher mean HADS-A (5.3 ± 3.4 for control and 4.4 ± 4.0 for intervention group patients) than mean HADS-D (3.5 ± 2.8 for control and 3.8 ± 3.6 for intervention group patients) at six weeks post-stroke. Interestingly, predictive factors for depression as lower age and decreased physical functioning (Vermeer et al., 2018) were not frequent in the current sample group. This is in line with the low number of depression symptoms.
It was hypothesized that symptoms of anxiety and depression would decrease as a result of the intervention. The reduced symptoms of anxiety are thus in line with our expectations. Earlier research also found reduced anxiety on the HADS as a result of outreach care for stroke patients (Boter, 2004). Therefore, the screening seems to accurately capture symptoms of anxiety and the given aftercare decreases these symptoms. It is expected that the aftercare chosen based upon the screening results reduces anxiety, or makes patients feel more secure about where to find help when needed, which could on itself reduce symptoms of anxiety. However, the unchanged symptoms of depression are against our
care, in the form of social care coordination, reduced depression within three months post-stroke (Claiborne, 2006). These unexpected findings might be due to the sample size being too small, as sample size was smaller than officially needed. The low sample size is also visible in the 95% confidence interval in figures 3 and 4, suggesting this is a plausible explanation. Another possibility is that the given aftercare was not sufficient enough to reduce symptoms of depression within three months. Herein, several explanations are plausible. Firstly, the aftercare based upon screening might not have been the best form of therapy to treat symptoms of depression. Patients who received psychotherapy might have reacted more successfully to medications, or the other way around. Further research should explore the effects of adjusting the protocol for referral to rehabilitation services to a lower threshold protocol. Secondly, the given time of three months might have been too short to reduce symptoms of depression. Perhaps the screening was accurate, but the treatment has not yet been successful. Further research should determine the longer-term effects of current intervention on symptoms of depression, which will be done in the ECO-stroke trial. In addition to this, patients not accepting sufficient aftercare could also explain the unchanged amount of depression symptoms. The reason for not accepting sufficient care might be that elderly patients sometimes feel uncomfortable labeling themselves with depression (Gallo and Rabins, 1999).
When the HADS-A and HADS-D cut-offs were applied, no significant differences in anxiety and depression were found as a result of the screening intervention. Only few patients (5%-32%, representing 1-7 patients) scored above these cut-offs, meaning either only few experienced serious anxiety and depression problems, or the cut-off is too high. As earlier research confirmed the cut-off to be valid (Bjelland et al., 2002), it is more plausible that few patients in our sample experienced serious anxiety and depression problems. In line with this, symptoms of stroke depression might not be severe within three months post-stroke, as post-stroke depression is known to be most severe at six months to two years post-stroke (Parikh et al., 1989). This could explain the small number of patients scoring above cut-off which results in less chance of finding a significant effect of the intervention. Further research should enlarge the sample size to better determine the effects of current intervention when applying the cut-off. As well as this, overall longer-term effects on anxiety and depression should be explored. Both will be done within the complete ECO-stroke trial.
Current research holds several limitations. Firstly, the performed randomization was a cluster randomization wherein hospitals were randomized rather than randomizing the patients on an individual level. In a cluster randomization design, patients are not as well spread over the control and intervention groups as would be with individual randomization. Influences of the
hospital itself, the hospital’s location or the hospital’s specialized nurses on outcomes cannot be excluded. By allocating five hospitals to each group, control and intervention, we hope to have limited these influences. Despite the above, cluster randomization was believed to be the best option for current study. As the consultations in each hospital were performed by the same specialized nurse, performing individual randomization would have led to the same specialized nurse treating both control and intervention group. When doing so, it is inevitable for the consultations to be at least slightly mixed up by the specialized nurse. To prevent such contamination, a cluster randomization was performed. Secondly, even though patients were blinded, clinicians and researchers were not blinded. However, as the second questionnaire was filled in by the patients themselves, without assistance of the clinicians and researchers, effects of not double-blinding are expected to be limited. Thirdly, part of the research was conducted during the SARS-CoV-2 outbreak. During the outbreak, no patients were included in the study, which caused the sample size to be slightly smaller than expected. However, sample size was sufficient to determine the effects of current intervention on emotional problems.
Strengths of the study firstly include that a rather important problem is assessed, which is the need to reduce post-stroke emotional problems, as stated in earlier research (Harrison et al., 2017, Fure et al., 2006). Secondly, the study used the HADS which is a validated screening measurement, which increases reliability of the study’s results. Thirdly, as the screening was performed by specialized nurses in the hospital, this directly represents clinical practice and thereby eases possible future implementation. Implementing the screening in hospital protocols should be considered. However, few challenges come with applying the screening in hospital protocols. Firstly, the intervention consultations lead to higher expenses as the consultations are more time consuming for the specialized nurses and require more room in hospitals. However, overall social costs are expected to be lower because patients will probably be able to return to work sooner, as less symptoms are experienced. As well as this, if patients experience less anxiety due to the intervention, these patients might have to visit doctors or psychologists less frequently, which decreases costs as well. The full ECO-stroke study will perform a cost-effectiveness analysis which will most probably answer these questions. Since results showed that only anxiety, and not depression, was decreased after the intervention, it is recommended to use current screening only to reduce anxiety problems. Even though these results seem hopeful for improving hospital protocols, it is recommended to wait for results of the full ECO-stroke trial to consider longer-term effects of the intervention as well. To increase employability of the screening intervention, further research should investigate the effects of current intervention on anxiety and depression in
results, applying the screening for all ischemic stroke patients, rather than minor stroke patients only, should be considered.
To conclude, current screening intervention seems promising for applying in hospital protocols to reduce post-stroke anxiety within three months in ischemic stroke patients discharged home. The ECO-stroke trial should determine the effects of the intervention on post-stroke depression as well as the overall longer-term effects of the intervention before implementing the intervention in hospital protocols. Further research should also explore the effects on anxiety and depression in patients who experienced more severe ischemic strokes.
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