Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

Study Overview
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Brief Summary
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Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

Detailed Description
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At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up measures will be performed within a week after the end of the intervention, and 6 months thereafter, in order to examine long term effectiveness. Outcome measures are questionnaires; change will be assessed by the difference in total score between T1 |(pre-intervention), T2 (post-intervention) and T3 (after 6 months)

Official Title
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Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Self-Management group-intervention
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebrovascular accident diagnosed 3-18 months before enrollment. Treated at th Neurologic Rehabilitation Center of Clalit Health Services in Kiryat Byalik, Israel. Living in the community (in their homes). Are capable of basic communication in Hebrew. Exclusion Criteria: Moderate-severe stroke (National Institutes of Health Stroke Scale (NIHSS) score ≤ 16). Moderate-Severe Cognitive impairment (Montreal Cognitive Assessment (MOCA) - total score ≤ 16). Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management group-intervention<br>Participants will receive Self-Management group-intervention + Standard Care | Behavioral: Self-Management group-intervention<br>* At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.<br>|
| Active Comparator: Standard Care<br>Participants will receive Standard Care only | Behavioral: Standard Care<br>* At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Participation | The primary outcome measure is the change in patient's participation, as defined by the International Classification of Function, Disability and Health (ICF), between the three assessment points - baseline, 12 and 36 weeks. | 12 and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for self-management behaviors. | Self-efficacy for self-management behaviors. | 12 and 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-Management, Stroke, Intervention, Group Processes