Clinical trial NCT02289287: Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.
Official title: Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Self-Management
Stroke
Intervention
Group Processes
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: University of Haifa
First posted: 2014-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: Patient Participation
timeFrame: 12 and 36 weeks
Secondary outcomes:
measure: Self-efficacy for self-management behaviors.
timeFrame: 12 and 36 weeks
Other outcomes:
Locations:
city: Haifa,
country: Israel
facility: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Study officials:
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: Tamar Adar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Therapy, Faculty of Social Well fare and Health Sciences, Haifa University, Haifa, Israel.
name: Eli Carmeli, PhD
role: STUDY_CHAIR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: Hagit Harel-Katz, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
name: Uzi Milman, MD
role: STUDY_DIRECTOR
References:
citation: 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.