| | Effect of a Home Leisure Education Program After Stroke: A Randomized Controlled TrialAbstract Desrosiers J, Noreau L, Rochette A, Carbonneau H, Fontaine L, Viscogliosi C, Bravo G. Effect of a home leisure education program after stroke: a randomized controlled trial. ObjectiveTo evaluate the effect of a leisure education program on participation in and satisfaction with leisure activities (leisure-related outcomes), and well-being, depressive symptoms, and quality of life (primary outcomes) after stroke. DesignRandomized controlled trial. SettingHome and community. ParticipantsSixty-two people with stroke. InterventionExperimental participants (n=33) received the leisure education program at home once a week for 8 to 12 weeks. Control participants (n=29) were visited at home at a similar frequency. Participants were evaluated before and after the program by a blinded assessor. Main Outcome MeasuresChange from preintervention to postintervention in: minutes of leisure activity per day, number of leisure activities, the Leisure Satisfaction Scale, the Individualized Leisure Profile, the General Well-Being Schedule (GWBS), the Center for Epidemiological Studies Depression Scale, and the Stroke-Adapted Sickness Impact Profile (SA-SIP30). ResultsThere was a statistically significant difference in change scores between the groups for satisfaction with leisure with a mean difference of 11.9 points (95% confidence interval [CI], 4.2−19.5) and participation in active leisure with a mean difference of 14.0 minutes (95% CI, 3.2−24.9). There was also a statistically significant difference between groups for improvement in depressive symptoms with a mean difference of −7.2 (95% CI, −12.5 to −1.9). Differences between groups were not statistically significant on the SA-SIP30 (0.2; 95% CI, −1.3 to 1.8) and GWBS (2.2; 95% CI, −5.6 to 10.0). ConclusionsThe results indicate the effectiveness of the leisure education program for improving participation in leisure activities, improving satisfaction with leisure and reducing depression in people with stroke. MANY PEOPLE WHO have had a stroke will have difficulty resuming their previous activities and roles and will be exposed to restrictions in participation in several life domains.1, 2 A significant decline in leisure participation after stroke has been observed,3, 4, 5, 6 especially in “active” leisure pursuits7 with a potential impact on quality of life (QOL).8 Leisure refers to activities performed in a context of freedom and spontaneity. Although it may be enjoyed for its own sake, purely for pleasure and freedom, leisure can also have important health benefits.9 Participation in and satisfaction with leisure have been found to be indicators of QOL and well-being.10 Depressive symptoms that are frequently observed after stroke11, 12 are associated with lower QOL13 and less variety in leisure activities.14 To our knowledge, the literature reports only 5 randomized clinical studies designed to determine the effect of leisure rehabilitation for people with stroke.15, 16, 17, 18, 19 These studies had conflicting results regarding the effects of leisure therapy, some reporting improvement in mood, leisure participation, and satisfaction,16, 17, 19 whereas others did not find such outcomes.15, 18 In the study by Jongbloed and Morgan,15 the absence of change could be attributable to the control participants who also discussed the topic of leisure with the therapist, as well as to the limited intervention duration and frequency. However, the well-designed multicenter study carried out by Parker et al,18 based on the positive results of Drummond and Walker’s study,17 did not find better outcomes on a leisure questionnaire. Their program, like others, was mainly based on the practice of leisure activities. Except for a pilot study,19 the effect of a leisure education program, which goes beyond the practice of leisure activities and emphasizes empowerment, has not been previously studied. The purpose of this study was to evaluate the effect of a home leisure education program with an emphasis on empowerment for people with stroke. The leisure-related outcomes were leisure participation and satisfaction related to this participation. The primary outcomes were general well-being, depressive symptoms, and health-related QOL (HRQOL). Methods  Design This study was a randomized controlled trial with blinded assessment of outcomes. Experimental participants received the leisure education program at home. Control participants were visited at home for a similar number of visits. Participants and Randomization A total of 62 people entered the trial carried out in 2002 and 2003. We recruited them after a review of medical charts of people who were previously admitted with stroke to a rehabilitation or acute care facility up to 5 years before the study. They were randomized to 2 groups, with 33 in the experimental group and 29 in the control group. In addition to the clinical diagnosis of stroke, inclusion criteria were: (1) living in the community and (2) self-report of some problems with leisure participation or satisfaction. People were asked to talk about their leisure activities and had to identify a loss of satisfaction with or participation in leisure, when compared with the pre-stroke period. We excluded people with: (1) cognitive problems (score ≤5th percentile on the Modified Mini-Mental State [3MS] Examination20 according to age and schooling21), (2) language comprehension problems as judged by whether the person could participate in a simple conversation, and (3) severe comorbidities (lower-limb amputation; degenerative neurologic conditions such as Parkinson’s and multiple sclerosis; cancer; severe hearing or visual loss). This study was approved by the research ethics committee of the facility where they were recruited. All patients provided informed consent. A general evaluation of the eligibility criteria was made during a phone call, and visits to the participants’ own environments confirmed their eligibility. We evaluated the participants prior to randomization (baseline [t1]) and after the end of the program (t2). An occupational therapist, not involved in the program and blinded to group assignment, was responsible for administering the outcome measures at t1 and t2. After baseline assessment, we randomly assigned the participants to the control and experimental groups. The concealed allocation schedule was computer-generated with blocking and stratification based on functional independence (Système de mesure de l’autonomie fonctionnelle [SMAF],22 score, <15 or ≥15) and time since stroke (<1y or ≥1y). Study Procedures The experimental intervention was provided by 2 study personnel: another occupational therapist and a recreational therapist. The recreational therapist was responsible for the intervention (see below) whereas the occupational therapist acted as a consultant, her role being to facilitate leisure participation, mainly by adapting the material or the environment. The control group participants were also visited by the recreational therapist but the topics discussed were unrelated to leisure (eg, family, cooking, politics, news, everyday life). The therapists met the participants once a week (8−12wk), theoretically for 60 minutes, but the duration for the experimental group was slightly longer because the leisure activities took place both at home and in the community, whereas the control intervention was carried out at home. Experimental Program: Leisure Education Program The program objectives were to enhance the participants’ personal empowerment with a view to optimizing leisure experiences.19, 23 The program was divided into 3 components. First, leisure awareness, which is defined as the perception and knowledge people have of their leisure activities and how important they consider them. Self-awareness relates to people’s perception of themselves, and their values, attitudes, and capacities in regard to leisure activities. Finally, competency development encompasses the perceived and real constraints identified by the person and knowledge of alternatives to achieve autonomy in leisure activities. The program is divided into 12 steps (fig 1). The maximum duration of the intervention for a participant usually does not exceed 12 sessions. The recreational therapist judged that a person had reached the end of the program when the following 2 conditions were present: (1) the participant had gone through all the steps in the program and (2) the person had integrated significant leisure activities in her/his life. Baseline measures We measured sociodemographic variables (table 1) at baseline. For stratification purposes, we used the SMAF to assess functional independence in 29 activities of daily living (ADLs), mobility, communication, mental functions, and domestic tasks.22 A higher score indicates more disability. The comorbidity index24 was also assessed. A higher score indicates more numerous or more severe comorbid conditions. Leisure-related outcome measures Participation in leisure was estimated in terms of duration (in minutes per day) for each leisure activity and recorded with the time budget technique,25 which determines the person’s daily leisure activities on a weekly basis (7 consecutive days) via a logbook. These activities were classified as passive and active leisure. The passive leisure score referred to the duration of activities that were done at home and required no active involvement (eg, listening to music, watching television, stroking one’s pet). The active leisure score included participation in social activities (eg, restaurant with friends, singing in a choir), entertainment and activities outside the home (eg, shopping for pleasure, car ride), physical activities (eg, bowling, taking a walk, exercising for pleasure), spirituality (eg, going to church, attending a conference), games, arts and crafts (eg, computer, playing cards, painting), and ADLs for pleasure (eg, small jobs inside and outside, looking after one’s bird). In addition, the number of different activities performed was calculated. The reliability of this method of measurement is not known. Satisfaction with leisure was estimated with 2 questionnaires. The Leisure Satisfaction Scale26 measures the degree to which people’s personal needs are met through their leisure activities (24 items scored from 1 to 5; higher scores indicate greater satisfaction). Content validity was verified with 160 professionals working in the leisure field. The reliability study (internal consistency) showed a Cronbach α coefficient of .93, with a range of .85 to .92 for the subcategories. In addition, we used 2 sections of the Individualized Leisure Profile,27, 28 related to satisfaction with: (1) needs and expectations in regard to leisure (14 items; Cronbach α=.92), and (2) use of spare time (10 items; α=.90). Each item is scored on a scale from 0 to 3, a higher score indicating a higher level of satisfaction. Primary outcome measures We used the General Well-Being Schedule29 to evaluate perceived well-being and symptoms of distress. The 18 items of this questionnaire measure 6 dimensions: anxiety, depression, positive well-being, emotional control, vitality, and general health. A 6-level (0 to 5) ordinal scale that varies with each question is used to answer the first 14 items. For the last 4 items, a visual analog scale from 0 to 10 with opposite feelings at each end of the scale is used. A higher score (maximum, 110) indicates a higher level of well-being. Three categories of score have been defined: severe distress (0−60); moderate distress (61−72); and positive well-being (>72).30 This tool has good test-retest reliability (intraclass correlation coefficient, .82).31 Depressive symptoms were estimated with the Center for Epidemiological Studies Depression Scale (CES-D).32 This questionnaire comprises 20 items rated from 0 to 3, with a lower score suggesting a lower level of depressive symptoms. This tool has been found to be reliable (interrater: r=.96) and valid as a screening tool for assessing depression in people with stroke,33 as well as specific and sensitive.34 Finally, we used the Stroke-Adapted Sickness Impact Profile (SA-SIP30)35 to evaluate HRQOL. The SA-SIP30 comprises 30 items divided into psychosocial and physical components. One point is given when an item is checked. Higher scores indicate poorer health. The SA-SIP30 is reliable (internal consistency of the total score, .85)36 and responsive to change.37 Construct and convergent validity have been demonstrated by comparison with the original SIP developed by Bergner et al.38 Statistical Analyses and Sample Size We determined the comparability of the groups at baseline using t tests for independent samples (continuous variables) or chi-square tests (categorical variables). Differences between pretest and post-test (intragroup) were compared using the paired t test. Between group differences were examined by calculating and comparing the mean change scores for each dependent variable. Statistical testing was done using an independent groups t test. The analyses were not carried out with the principle of intention to treat because the participants who dropped out were not available for re-evaluation. We aimed at recruiting 26 participants per group to detect a moderate to large effect (.70) according to Cohen’s criteria with a statistical power of 80% and a 2-sided α error of 5%.39 The standardized difference (effect size, .70) was based on a preliminary study in which variability in participants’ QOL data had a standard deviation (SD) of 2.9 and a minimum clinically significant difference of approximately 2.19 We also used well-being data from a study carried out with persons with stroke who received day hospital services that showed an SD of 13 and minimal clinically significant difference of approximately 8.40 Results The flowchart of the participants is presented in figure 2. The 42 eligible people who refused to participate did not differ from those who agreed: age, 72.4±12.1 years versus 70.8±10.8 years (P=.48); and sex ratio of women to men of 20 to 22 versus 32 to 30 (P=.69). Four participants dropped out, all from the experimental group, and 2 participants from the control group were not measured at t2 for technical reasons, leaving 29 and 27 participants respectively for the analyses. The reasons for dropping out were sickness (n=2) and refusal to continue after the first session (n=2). The dropouts had more functional disabilities than those who participated, as estimated with the SMAF (36.5±10.9 vs 19.8±0.6; P=.008). The experimental and control groups were equivalent at baseline (see table 1) with the exception of HRQOL, which was lower in the control group. The experimental group received more sessions (range, 8−12; mean, 10.1±1.2) than the control group (range, 8−11; mean, 9.5±0.9) (P=.035) as well as a longer duration per session (mean, 76.9min vs 65.8min; P<.001). Leisure-Related Outcomes Participation in and satisfaction with leisure are presented in table 2. Daily duration of active and passive leisure activities was similar at t1. However, at t2, the experimental group had more active than passive leisure activities. The difference between groups was significant for the active leisure activity duration as well as for the number of activities, as indicated by the 95% confidence intervals (CIs). There was no difference between the groups in the duration of passive leisure activities. Satisfaction with leisure increased only in the experimental group and the differences between the groups were statistically significant, except for satisfaction with the use of spare time. Primary Outcomes The well-being of the experimental group increased during the program but the differences between groups was not significant (see table 2). Both groups statistically improved their HRQOL but no difference was found between them. However, only the experimental group significantly reduced their depressive symptoms after the program and statistical testing between groups was significant (95% CI, −12.5 to −1.9; P=.01). Discussion The purpose of this study was to evaluate the impact of a home leisure education program focusing on empowerment for people who had a stroke. Many clinical guidelines for stroke, such as that published by Duncan et al,41 recommend that leisure activities be identified and encouraged and that the patient be enabled to participate in these activities. The main finding of the study was that some dimensions of leisure improved after the program, with a concurrent impact on depressive symptoms. After the leisure education program, persons in the experimental group increased their participation in active leisure activities and were more satisfied with their leisure activities. The significant increase in time involved in active leisure activities in the experimental group tends to support the view that the leisure program stimulated people to enhance their leisure participation. However, one can argue that the mean difference of 14 minutes a day found between the groups is modest and not clinically significant, particularly if we consider the lower 95% CI (3.2min). The program did not focus directly on increasing the amount of leisure time but mainly targeted a form of personal empowerment of the participants by offering an education process that, one would hope, would lead to personal management of leisure participation. This kind of program was thus more likely to increase satisfaction, which is generally more important than the amount of leisure activities.42, 43 After the program, the experimental group presented fewer depressive symptoms than those who did not receive the program. The magnitude of the improvement in the experimental group is high and appears to be clinically important, although the lower 95% CI is only 2 points. Based on the threshold score of 16 for depression in the CES-D,34 both groups were considered depressed at t1 but not at t2, especially the experimental group, who considerably reduced (nearly 50%) their depressive symptoms. No statistically or clinically significant differences were found between the groups’ well-being (2 points on a scale of 110) or HRQOL (0.2 points on a scale of 30). The concept of well-being is, to some extent, related to depression, but well-being is also associated with other components such as vitality and general health, which could have remained relatively stable over time. This is consistent with the HRQOL scores, which were rather stable (small differences, even though statistically significant) over time for both groups. Also, even though no significant difference between the groups was found in regard to well-being, at pretest both groups were classified in the moderate distress category, whereas at post-test they had moved into the positive well-being category (>72).30 These results can also be discussed in relation to previous randomized studies. In the study by Jongbloed and Morgan,15 carried out with 40 people who had had a stroke in the previous 15 months, participants in the experimental and control groups were visited 5 times by an occupational therapist for 60 minutes. No difference was found between the 2 groups in regard to leisure participation and satisfaction as well as depressive symptoms. These nonsignificant results might be attributable to an unexpected positive impact on the control group participants, who also had discussions with the therapist about leisure or, conversely, to the limited duration and frequency of the intervention, which was not sufficient to modify leisure patterns. Drummond and Walker’s clinical trial16, 17 that randomly assigned 60 participants to 3 groups—(1) leisure rehabilitation program at home (experimental group), (2) occupational therapy at home, and (3) no visits—reported a significantly higher participation rate in social and leisure activities in the experimental group than in the others (P=.001)16 and the difference remained significant 6 months poststroke (P=.01).17 The leisure rehabilitation program also had a positive effect on the participants’ psychologic well-being 3 months after discharge from hospital. After such promising results, Parker et al18 studied the effects of a leisure-based occupational therapy intervention on mood, leisure participation, and independence in ADLs in people who had had a stroke. In this multicenter study, 466 people were divided into 3 groups: (1) leisure, (2) ADLs, and (3) control. Contrary to the previous study, none of the outcomes that were measured at 6 and 12 months after discharge from hospital improved or differed between the groups. The diversity in the content of the programs that were investigated might explain the differences in the results of these studies. Although different, all these programs were based on the practice of leisure activities, which was not the case in our educational program. Indeed, in the leisure education program, only a part is devoted to some leisure practice. The program is mainly based on an educational process that aims to enhance the empowerment of participants in optimizing their leisure. By recognizing the importance of leisure in their lives, by having a better perception of their value and residual abilities, and by developing competency in using and integrating resources related to leisure, participants might achieve a higher level of engagement in leisure. Study Strengths This study has some important strengths that support its findings. The experimental design, blinded assessments, and the use of valid and reliable primary measures minimized potential biases. The placebo intervention ensured that all participants received a similar degree of attention over the course of the study and thus the increased benefits of the experimental group can be more reasonably attributed to the leisure education program. Study Limitations Some study limitations must also be considered. The reliability of the method of measurement of leisure duration and number of activities is not known; hence, random error may have reduced the responsiveness of this measure. There was a slight difference in duration and frequency of the interventions between the groups because parts of the experimental program were carried out in the community. A dropout bias is also possible because those who stopped participating in the experimental group had lower functional independence than those who did not. The lack of a follow-up at 6 months and 1 year should also be considered a limitation. Conclusions The ultimate purpose of the stroke rehabilitation process is to help people optimize resumption of premorbid activities. We found that an empowerment-focused home leisure education program had a positive effect on leisure satisfaction and participation, with benefits for mood in community-dwelling persons with stroke. Further research is needed to replicate our findings and longer term follow-up assessments are needed to evaluate the durability of the effects. Acknowledgment We thank Lise Trottier, MSc, for her help with the statistical analyses. 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42. 42Brown AB, Frankel BG. Activity through the years: leisure, leisure satisfaction, and life satisfaction. Sociology Sport J. 1993;10:1–17. 43. 43Lloyd K, Auld CJ. The role of leisure in determining quality of life: issues of content and measurement. Soc Indic Res. 2002;57:43–71. a Research Centre on Aging, University Institute of Geriatrics of Sherbrooke, Sherbrooke, QC, Canada b Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, QC, Canada c Center for Interdisciplinary Research in Rehabilitation and Social Integration, Rehabilitation Department and Université Laval, Quebec City, QC, Canada d School of Rehabilitation, Université de Montréal, Montreal, QC, Canada.  Correspondence to Johanne Desrosiers, PhD, Research Centre on Aging, 1036 Belvédère sud, Sherbrooke, QC J1H 4C4, Canada
Supported by the Canadian Institutes of Health Research (grant no. MOP-49526). No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the authors or upon any organization with which the authors are associated. Reprints are not available from the author. PII: S0003-9993(07)00437-6 doi:10.1016/j.apmr.2007.06.017 © 2007 American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved. | |
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