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

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Behavioral: Self-Management group-intervention; Behavioral: Standard Care

• Registration Number: NCT02289287
• Lead Sponsor: Uzi Milman

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.

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 Timeline

• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-13
• Study Start: 2017-04-17
• Status Verified: 2019-09
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Management group-intervention	Self-Management group-intervention	Participants will receive Self-Management group-intervention + Standard Care
Standard Care	Standard Care	Participants will receive Standard Care only

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Self-efficacy for self-management behaviors.	12 and 36 weeks	Self-efficacy for self-management behaviors.

Trial Locations

Locations (1)

Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,; 🇮🇱 Haifa,, Israel