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

U

Uzi Milman

Status

Terminated

Conditions

Stroke

Treatments

Behavioral: Self-Management group-intervention
Behavioral: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02289287
COM - 0018-14-CTIL

Details and patient eligibility

About

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.

Full 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)

Enrollment

60 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Self-Management group-intervention
Experimental group
Description:
Participants will receive Self-Management group-intervention + Standard Care
Treatment:
Behavioral: Self-Management group-intervention
Standard Care
Active Comparator group
Description:
Participants will receive Standard Care only
Treatment:
Behavioral: Standard Care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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