Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Self-Management group-intervention Participants will receive Self-Management group-intervention + Standard Care |
Behavioral: Self-Management group-intervention
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.
|
| Active Comparator: Standard Care Participants will receive Standard Care only |
Behavioral: Standard Care
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.
|
Outcome Measures
Primary Outcome Measures
- Patient Participation [12 and 36 weeks]
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.
Secondary Outcome Measures
- Self-efficacy for self-management behaviors. [12 and 36 weeks]
Self-efficacy for self-management behaviors.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, | Haifa, | Israel |
Sponsors and Collaborators
- Uzi Milman
- University of Haifa
Investigators
- Principal Investigator: Tamar Adar, MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
- Study Chair: Eli Carmeli, PhD, Department of Physical Therapy, Faculty of Social Well fare and Health Sciences, Haifa University, Haifa, Israel.
- Principal Investigator: Hagit Harel-Katz, MSc, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
- Study Director: Uzi Milman, MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COM - 0018-14-CTIL