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

NCT02289287 | Terminated

• 1 other identifier: COM - 0018-14-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Self-Management; Stroke; Intervention; Group Processes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-efficacy for self-management behaviors.

  12 and 36 weeks

Study Arms (2)

Self-Management group-intervention

EXPERIMENTAL

Participants will receive Self-Management group-intervention + Standard Care

Behavioral: Self-Management group-intervention

Standard Care

ACTIVE COMPARATOR

Participants will receive Standard Care only

Behavioral: Standard Care

Interventions

Self-Management group-intervention BEHAVIORAL

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.

Self-Management group-intervention

Standard Care BEHAVIORAL

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.

Standard Care

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uzi Milman: lead
• University of Haifa: collaborator

Study Sites (1)

Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,

Haifa, Israel

Location

Related Publications (1)

• Harel-Katz H, Adar T, Milman U, Carmeli E. Examining the feasibility and effectiveness of a culturally adapted participation-focused stroke self-management program in a day-rehabilitation setting: A randomized pilot study. Top Stroke Rehabil. 2020 Dec;27(8):577-589. doi: 10.1080/10749357.2020.1738676. Epub 2020 Mar 14.

  PMID: 32174261 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Tamar Adar, MD

  Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

  PRINCIPAL INVESTIGATOR

• Eli Carmeli, PhD

  Department of Physical Therapy, Faculty of Social Well fare and Health Sciences, Haifa University, Haifa, Israel.

  STUDY CHAIR

• Hagit Harel-Katz, MSc

  Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

  PRINCIPAL INVESTIGATOR

• Uzi Milman, MD

  Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: April 17, 2017
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)