Abstract
Objective:
Compare caregiver burden, provision of informal care, participation in everyday occupations and life satisfaction of caregivers to people with stroke, who either had received a client-centred, activities of daily living intervention or usual activities of daily living interventions.
Design:
A multicentre cluster randomized controlled trial in which 16 rehabilitation units were randomly assigned to deliver a client-centred, activities of daily living intervention or usual activities of daily living interventions. Caregiver outcomes were compared cross-sectionally at 12 months and changes in outcomes between three and 12 months after people with stroke were included in the study.
Setting:
Inpatient and outpatient rehabilitation.
Participants:
Caregivers of people with stroke enrolled in the trial.
Intervention:
A client-centred, activities of daily living intervention aiming to increase agency in daily activities and participation in everyday life for people after stroke.
Main measures:
Caregiver Burden Scale, Occupational Gaps Questionnaire, LiSat-11.
Results:
There were no differences in outcomes between caregivers in the client-centred, activities of daily living (n = 88) and the usual activities of daily living (n = 95) group at 12 months. The caregiver burden score was 42.7 vs. 41.8, p = 0.75, mean occupational gaps were 3.5 vs. 4.0, p = 0.52 and satisfaction with life was 53% vs. 50%, p = 0.87. There were no differences in changes between three and 12 months. However, within groups there were significant differences in caregiver burden, factor general strain, for caregivers in the client-centred, activities of daily living group, and in provision of informal care for the usual activities of daily living group.
Conclusion:
The client-centred intervention did not bring about any difference between caregiver-groups, but within groups some difference was found for caregiver burden and informal care.
Introduction
Everyday life after stroke can be challenging, not just for the person with stroke, but also for their caregivers. A caregiver is a term commonly used in the literature to represent informal caregivers, and is in this study defined as a relative, partner, friend or neighbour who in some way supports or is being there for the person with stroke, although the caregiver may not consider him or herself as a caregiver. After stroke, restricted participation in everyday life1,2 and low life satisfaction is common,1,3 for both the persons with stroke and their caregivers, and this has been found to be associated with caregiver burden.1,4
The goal of rehabilitation after stroke is commonly defined as increasing functioning and well-being 5 and one way of reaching this goal is to focus on activities of daily living (ADL) training, which has shown good effect on independence in ADL. 1 It has also been suggested that improved ADL-functioning for the person with stroke may decrease caregiver burden, however few intervention studies have described the effect on caregiver burden 6 and perceived life satisfaction.7–9 Tailored interventions in which health professionals focus on providing information, emotional and practical support and use strategies that actively involve the caregivers, have been reported to have beneficial effects for both the person with stroke and the caregivers.6,10–12 Involving the caregivers in rehabilitation has been stated to decrease patient anxiety and depression 13 and caregivers participation in problem-solving to be associated with greater preparedness and improvements in their mental health. 14
Rehabilitation interventions aiming to increase ability and independence in ADL need to be further defined, and effects evaluated both for people with stroke and their caregivers. Therefore, a client-centred ADL intervention was developed with the aim to increase independence in ADL, enable the person with stroke to be an active agent in daily activities and participation in everyday life. However, short-term (three months) 15 and long-term (12 months) follow-ups 16 revealed no differences in the primary outcome perceived participation between people with stroke who had received the client-centred ADL intervention and those who had received usual ADL interventions.
Although the caregivers were not the target of the intervention, a hypothesis was that caregivers of people with stroke who received the client-centred ADL intervention would perceive lower caregiver burden and higher life satisfaction at three months compared with the caregivers of those who received the usual ADL intervention after stroke. The comparison between caregivers in the client-centred ADL group and the usual ADL group at three months 15 showed that there were no differences in outcomes between the groups. However, it has been found that this first time period after stroke can be chaotic both for the persons with stroke and the caregivers.17,18 Despite the fact that people with stroke make improvements in ADL, caregivers still report burden several years after stroke. 19 Thus, it is important to evaluate the effect of the client-centred ADL intervention on caregiver burden with a long term follow-up, when the first chaotic months after stroke have passed. Therefore, the aim of this study was to compare the effects of a client-centred ADL intervention to usual ADL interventions on the caregivers’ burden, provision of informal care, participation in everyday occupations and life satisfaction up to 12 months after the person with stroke was included in the study.
The following research questions were addressed.
Are there any differences between the caregivers in the client-centred ADL group and the usual ADL group at 12 months in caregiver burden, provision of informal care, perceived participation in everyday occupations and life satisfaction?
Are there any differences between the groups in changes between three and 12 months in caregiver burden, provision of informal care, perceived participation in everyday occupations and life satisfaction?
Methods
Design
This was a longitudinal study of caregivers in the context of a multicentre cluster randomized controlled trial in which people with stroke either received a client-centred ADL intervention, the intervention group, or usual ADL interventions, the control group. The multicentre study was conducted in 16 participating rehabilitation units in three Swedish county councils representing both inpatient and outpatient rehabilitation. In Uppsala and Gävleborg County Councils, all units providing stroke rehabilitation were included. In Stockholm County Council, the units to which the stroke units mainly referred stroke patients for inpatient rehabilitation and the home rehabilitation units that were willing to participate were included. The units were, after inclusion, randomly assigned to deliver the client-centred ADL intervention or usual ADL interventions, stratified by type of rehabilitation (inpatient <65 years of age, inpatient ⩾65 years, home rehabilitation). The occupational therapists in the participating units did not need to meet any specific requirements.
Participants
Eligible for inclusion in the randomized controlled trial were people: (a) treated for stroke in a stroke unit, no longer than three months after stroke onset; (b) dependent in at least two ADL domains according to Katz Extended ADL Index; 20 (c) not diagnosed with dementia; (d) able to understand and follow instructions; and (e) referred for rehabilitation to one of the 16 participating units. Follow-ups of the people with stroke were performed in their homes at three, six and 12 months after inclusion in the study by assessors blinded to which rehabilitation units were delivering the client-centred ADL intervention or the usual ADL interventions. The primary outcome was perceived participation at 12 months, as measured with domain eight of the Stroke Impact Scale. 21 Power calculations and adjustments for attrition revealed that 280 participants should be included in order to detect a clinically meaningful difference in perceived participation. The Barthel Index 22 was administered at inclusion and used in the present study to determine stroke severity, where scores of <15 represented a severe stroke, 15–49 a moderate stroke, and 50–100 a mild stroke. 23 The Bartel Index was also used at 12 months to measure independence in ADL. Detailed information on procedures for inclusion and follow-ups of participants with stroke has been reported elsewhere. 15
After informed consent was obtained and baseline assessments were performed for the persons with stroke, they were asked to name one caregiver they wanted to take part in the study and for permission to contact the named person. Eligible for inclusion in the present study were thus named caregivers, who were contacted, informed about the study and asked if they were willing to take part. At the three-month follow-up of the person with stroke, if possible, a meeting with the caregiver was scheduled too and consent to participate was obtained. If the caregiver was unable to be present at the three-month follow-up, information, questionnaires and self-reported measures were left or sent by postal mail and returned in a pre-stamped envelope.
Interventions
The client-centred ADL intervention implied that the participants with stroke were actively involved in their rehabilitation enabling ADL and that the intervention was specifically guided by their needs and expressed desires. 24 The persons’ lived experiences served as the point of departure for the occupational therapists in the client-centred ADL intervention. This intervention was developed in a series of mainly qualitative studies of the lived experience after stroke. Important parts of the intervention included creating a relationship between the person with stroke and the occupational therapist, setting goals together based on the person’s preferred activities. The client was introduced to use a global problem-solving strategy; goal – plan – do – check, inspired by Polatajko. 25 The strategies that the participant had used were jointly evaluated with the occupational therapist. 26 The client-centred ADL intervention focused on enabling the person with stroke to become an active agent in daily activities and participation in everyday life, and the caregivers were invited to participate in rehabilitation as much as they wanted.
The 44 occupational therapists that delivered the client-centred ADL intervention had all participated in a five-day workshop spread over one month. The workshops included lectures about concepts of client-centredness, theories behind the intervention, readings, discussions and reflections on scientific articles and case studies.
Participants who received their rehabilitation in a unit that was randomized to supply usual ADL interventions, did not receive a specific intervention, but rather were given a variety of strategies. This intervention varied in extent and methods according to the knowledge and clinical experience of the individual occupational therapist and according to the routines and praxis of the participating rehabilitation units. More detailed information of the client-centred ADL intervention and the usual ADL interventions has been presented elsewhere. 15
The occupational therapists in all participating units were contacted on a regular basis. For occupational therapists who delivered the client-centred ADL intervention, this was an opportunity to monitor and support their fidelity to the intervention.
Data collection
At the follow-up, three months after inclusion of the person with stroke in the study, demographic data on the caregivers were collected through the use of questionnaires, while data regarding caregiver burden, perceived participation in everyday occupations and life satisfaction were collected with validated instruments at three and 12 months. The participants responded to the questionnaires independently, however, if they had questions, the data collectors were available to provide support.
For descriptive information on the intervention given, a copy of the occupational therapy records was collected.
Measurements
Outcomes
Caregiver burden
To assess caregiver burden, the Caregiver Burden Scale 19 was used. The Caregiver Burden Scale contains 22 items covering areas of the caregiver’s health, feelings of psychological well-being, relations, social network, physical workload and environmental aspects. The items are scored on a scale from 1 to 4 and the higher the score the greater the burden. The Caregiver Burden Scale score is the calculated mean of all items. The instrument comprises five factors: general strain, isolation, disappointment, emotional involvement and environment. A mean value is calculated for each of the five factors. Furthermore, severity of burden can also be expressed as proportions with the following ranges of mean scores: low (1.00–1.99), moderate (2.00–2.99) or high burden (3.00–3.99). The Caregiver Burden Scale has been shown to have good construct validity and test–retest stability. 19
Informal care
The caregivers were asked to report whether or not they assisted the person with stroke (yes/no) in (a) personal ADL, (b) instrumental ADL, or in (c) other activities, which the person with stroke had performed independently prior to stroke.
Participation in everyday occupations
The Occupational Gaps Questionnaire 27 was used to assess perceived participation in everyday occupations. The Occupational Gaps Questionnaire is a checklist comprising 28 activities regarding instrumental ADL, work or work-related activities, leisure and social activities. For each activity there are two questions: (a) if the person performs the activity (yes/no) and (b) if the person wants to perform the same activity (yes/no). When there is a discrepancy between the responses to the two questions, an occupational gap is considered to be present. An optimal outcome is a low number of gaps. The gaps were categorized according to the participants’ age in agreement with results of a Swedish representative sample in which occupational gaps were found to vary with age. 28 Hence, each caregiver was categorized based on number of gaps into one of three groups: 0 = participants with no gaps; 1 = participants with one gap to median numbers of gaps in respective age group; 2 ⩾ median numbers of gaps in the age groups. The Occupational Gaps Questionnaire is a valid measure of perceived participation in everyday occupations. 27
Life satisfaction
One item in the life satisfaction scale LiSat-11, 7 ‘My life as a whole is’, was used to assess the caregivers’ overall satisfaction with life. The items in the LiSat-11 are scored on a six-step, ordinal scale ranging from (6) ‘very satisfying’ to (1) ‘very dissatisfying’. For the analysis, the score was dichotomized into satisfied (score 5–6) or not satisfied (score 1–4). The scale reduction with this dichotomy is considered to be valid and the LiSat-11 has been shown to have acceptable test–retest reliability, specificity and sensitivity. 7
Statistical methods
Descriptive statistics were used to present the characteristics of the participants at three and 12 months. For all statistical analyses, intention to treat was applied. In the case of missing values in the cross-sectional analysis, imputation with last value carried forward was applied if available or else the worst value of the study sample at three and 12 months was imputed. For the statistical analyses of differences between the groups at 12 months, univariate analyses of variance were performed for the Caregiver Burden Scale 19 and the Occupational Gaps Questionnaire. Multinomial/binomial logistic regression analyses were used for the LiSat-11 and information regarding informal care. To adjust for imbalances between the groups the following covariates were included in the models to adjust for factors that could impact the result: Type of rehabilitation unit, gender of the caregiver, cohabiting or not, age of the person with stroke, stroke severity and independence/dependence in ADL at three months according to Katz Extended ADL Index. 20
In order to analyse changes in the outcome variables between three and 12 months, a model involving a generalized estimating equation was fitted with the Genmod procedure in SAS® version 9.3 (Statistical Analysis System). The generalized estimating equation strategy is a useful approach for repeated measurements of binomial and ordered categorical data. Patients with missing data were included in the generalized estimating equation models, as this procedure can accommodate missing data. The model was set up with the between group factor Group (client-centred ADL intervention or usual ADL interventions), the within group factor Time (three and 12 months) and the interaction Group × Time.
For statistical significance, a p-value of 0.05 was accepted. For the statistical analysis, the SAS® version 9.3 and SPSS version 22 (Statistical Package for the Social Sciences) were used.
Results
Flow, baseline and follow-up data
Participant flow for the person with stroke at inclusion, and for caregivers at three and 12 months after inclusion in the study is illustrated in Figure 1. Between 21 January 2010 and 5 September 2012, 183 caregivers were recruited. Three caregivers were hindered to participate at the first data-collection, but participated at 12 months. In Table 1, characteristics of the caregivers and of the people with stroke having a caregiver participating in the study are presented together with outcome at 12 months: Independence/dependence in ADL. According to the occupational therapist records, contacts with the caregivers were equally distributed, mean 1.4 and 1.5 times, respectively.
Flowchart.
Characteristics of caregivers and of the people with stroke who had a caregiver participating in the study. Outcome at 12 months including imputed values on independence in ADL and home-help service.
ADL: activities of daily living.
Comparisons of outcomes at 12 months
In Table 2, outcomes of the caregivers at 12 months are presented. There were no differences between caregivers in the group receiving client-centred ADL intervention and the group receiving usual ADL intervention in the outcomes caregiver burden, in provision of informal care, their perceived participation in everyday occupations or life satisfaction. Neither were there any differences between the groups in the different Caregiver Burden Scale factors, nor in the age categorized Occupational Gaps Questionnaire.
Caregivers, outcomes at 12 months. Including imputed values.
0 = participants with no gaps; 1 = participants with one gap to median numbers of gaps in respectively age group; 2 ⩾ median numbers of gaps in the age groups.
Comparisons of changes in outcomes between three and 12 months
There were no differences between the client-centred ADL and the usual ADL group in changes in the outcomes between three and 12 months. However, for caregivers in the client-centred ADL group there was a statistically significant change over time in the factor General strain, with lower burden at 12 months than at three months: odds ratio 1.74 (CI 1.12–2.70) with a p-value of 0.014.
There was no significant difference in provision of assistance in personal ADL between the groups. However, for caregivers in the usual ADL group, there was a significant change-over time: odds ratio 3.42 (CI 1.23–9.50), with a p-value 0.02 for a smaller proportion of caregivers providing assistance at 12 months than at three months. There were no differences between the groups in changes between three and 12 months in instrumental ADL or in other support.
Discussion
To the best of our knowledge this is the first study to evaluate the long-term effects of a client-centred ADL intervention for people with stroke and its effect on the caregivers. At 12 months follow-up there were no differences between the caregivers in the client-centred ADL and the usual ADL group in the outcomes with regard to caregiver burden, in provision of informal care in ADL, their perceived participation in everyday occupations and life satisfaction. Neither were there any differences between the groups regarding changes between three and 12 months in the outcomes. However, the odds for caregiver burden were lower at 12 months compared with three months for the caregivers in the client-centred ADL group regarding the factor General strain. This result indicates that there were no differences in outcomes between caregivers to people who had received the client-centred ADL intervention and caregivers to participants who had received the usual ADL interventions, which is important as it is imperative to monitor the plausible negative impacts of new interventions on caregivers.
As there were no differences between the two groups of people with stroke in perceived participation or in dependence of assistance in ADL at 12 months after inclusion in the study 16 – the basis for a difference in caregiver burden in favour of the client-centred intervention was not present.
A cause for not capturing an effect of the intervention could be that data collected on informal care was dichotomized in providing vs. not providing care, as it was difficult in retrospect for the caregivers to estimate the amount of time they dedicated to care for the person with stroke. It is also possible that there might be a lack of effect because there were too little difference between the experimental and the control intervention. The possibility that the control intervention also included client-centred ways of providing ADL intervention cannot be eliminated because the client-centred perspective is a prevalent approach and favoured by many occupational therapists. A further reason for a lack of differences in outcomes between the groups could be that the instruments that were used did not catch the effect of a client-centred approach. However, our results showing no differences in outcomes are in line with those reported in a randomized controlled trial of a client-centred occupational therapy intervention for people with multiple sclerosis in which no difference in outcome were reported either. 29 Similar findings have also been reported in a systematic literature review of randomized controlled trials of patient-centred interventions, 30 in which small or no differences in outcomes were reported.
Thus, the result from the present study indicate that the use of a client-centred intervention with goal-setting and training in their own preferred activities does not appear to affect the outcomes for the significant other otherwise than the usual ADL intervention.
The client-centred ADL intervention was aimed to increase agency in daily activities and participation in everyday life after stroke for the person with stroke. Considering that the intervention did not primarily target the caregivers and that low or no effects have been reported in randomized controlled trials of interventions specifically aimed to support the caregivers of people with stroke, 31 the results of the present study are not surprising.
Despite, a lack of differences in outcomes between caregivers in the two groups, there were some important changes within the groups that warrant some attention. Caregivers’ perception of general strain decreased in the client-centred group between three and 12 months after inclusion in the study. However, contradictory findings regarding changes in caregiver burden during the first year after stroke has also been reported. 4 The large variation in previous studies with regard to, for example, study samples and instruments, used render comparisons with our findings problematic.
Since caregiver burden is a complex and multidimensional construct, 19 there may be several different aspects that influence the experience of burden. One reason for lower general strain might then be that the client-centred ADL enabled the person with stroke to become an active agent in his or her own rehabilitation process, which also positively influence the caregivers and prevent overbearing feelings of responsibility in everyday life. The awareness of activity goals might also reduce uncertainty or feelings of stress among caregivers when trying to provide the best care for the person with stroke. 32 Pierce et al. 33 stated that worrying negatively effects energy levels, which can lead to tiredness.
The ability to not take over an activity can also be considered an important factor in decreasing general strain. Visser-Meily et al. 34 found that using an avoiding coping strategy, for example ‘to walk away from the caring’ is associated with reduced burden. However, the result from the present study showed that the caregivers in the usual ADL group were partaking in informal caregiving to a lower extent at 12 months than at three months. Despite this, there was no decrease in caregiver burden in the usual ADL group between three and 12 months as in the client-centred ADL group. This result might be related to that, for the client-centred ADL intervention co-performance appeared in everyday activities, which can be seen as compensating for the loss of ability to perform a task alone. 35 Reciprocity is apparent when studying couple’s interaction in everyday activities after a stroke 17 and interdependence can be manifested in shared occupations or co-performance. 36 When persons perceive themselves and their care recipient as interdependent, caregiving has been shown to have a positive effect on well-being. 37
It is important to conduct clinical trials of complex interventions in order to provide cost effective healthcare, 38 but it is also a challenge to understand the different mechanisms of complex interventions. Strengths of the present study were the randomization of the rehabilitation sites, rather than the individuals that decreased the risk of contamination, and that the data collectors and statistician were blinded to which rehabilitation site provided which ADL intervention. Additional strengths were the inclusion of covariates in the analyses to accommodate for factors that might impact the outcomes, the longitudinal design and that intention to treat analyses were performed in line with CONSORT. 39 However, a limitation of this study was that the power calculations for the randomized controlled trial were made on outcomes related to the participants with stroke and not with regard to outcomes related to the caregivers. Furthermore, to obtain a deeper understanding of how the intervention works in the everyday life of the caregivers, there is a need to perform qualitative studies of how they experience a client-centred ADL intervention.
Clinical message
A new client-centred ADL intervention after stroke, which aims to increase agency in daily activities and participation in everyday life after stroke, does not appear to affect caregivers differently regarding life satisfaction, perceived participation, caregiver burden or provision of informal care at 12 months compared with usual ADL interventions.
Caregivers to people with stroke who receive a new client-centred ADL intervention appear to experience a decrease in general strain during the first year after stroke.
Footnotes
Acknowledgements
The authors wish to give a thanks for the caregivers of the persons with stroke and the staff at the different rehabilitation units in Stockholm, Gävleborgs- and Uppsala County Councils who participated in this study.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical approval
The regional Ethical Review Board in Stockholm approved the study. Registration Clinical Trials gov. identifier: NCTO 1417585.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The financial support of this study was carried out by The Swedish Research Council and funds at Karolinska Institutet. The regional agreement on medical training and clinical research (ALF) between Stockholm County Council and Karolinska Institutet, Uppsala-Örebro Regional Research Council, the Swedish Council for Working Life and Social Welfare.