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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02289287
• Other study ID #: COM - 0018-14-CTIL
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: September 19, 2019

Study information

• Verified date: September 2019
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 19, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,	Haifa,

Sponsors (2)

Lead Sponsor	Collaborator
Uzi Milman	University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-efficacy for self-management behaviors.	Self-efficacy for self-management behaviors.	12 and 36 weeks