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

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.

Conditions

• Stroke

Interventions

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.

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.

Sponsors & Collaborators

• University of Haifa

  collaborator OTHER

• Uzi Milman

  lead OTHER

Principal Investigators

• Tamar Adar, MD · Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

• Eli Carmeli, PhD · Department of Physical Therapy, Faculty of Social Well fare and Health Sciences, Haifa University, Haifa, Israel.

• Hagit Harel-Katz, MSc · Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

• Uzi Milman, MD · Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-17

Primary Completion

2019-09-19

Completion

2019-09-19

Countries

• Israel

Study Locations