The Effectiveness of the Adapted Bridge's Self-management Programme

NCT ID: NCT03271684

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-12-01

Brief Summary

The effectiveness of the adapted Bridge's self-management programme in South African community-dwelling stroke survivors: A randomized controlled trial with two arms will be used, with the intervention group receiving self-management sessions delivered by experienced therapists and usual care and control group will only receive usual care which includes a information booklet.

Detailed Description

This study aim to determine the effectiveness of the Adapted bridges self-management intervention on South African stroke patients' functional activity, self-efficacy, and participation. Method: This experimental study will make use of a randomized controlled design (RCT), consisting of one hundred and sixty eight stroke survivors recruited from different health care facilities within the Cape Metropolitan area. The study participants will be divided randomly into two groups, with one receiving the intervention - the experimental group - and the other receiving an educational booklet - the control group. Participants will be assessed at baseline, immediately post-intervention (six weeks), three and sixth-month post intervention, using standardized outcome measures (both subjective outcome measures and objective clinical tools). Ethical clearance and permission to conduct the study will be obtained and patient information will be kept confidential. Analyses will be conducted using descriptive statistics of frequencies and percentages for categorical variables and mean and standard deviation for continuous variables. Given the assumptions of equal variance, a two-way full factorial ANOVA will be computed in order to assess interaction between groups and intervention type.

Conditions

Self-Care; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

Will receive one session of up to one-hour per week over a six-week period in self-management in addition to their usual rehabilitation and workbook.

Group Type: EXPERIMENTAL

self-management

Intervention Type: OTHER

one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed

control group

Will receive booklet consist of home exercises and education besides the usual care

Group Type: OTHER

Control

Intervention Type: OTHER

Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.

Interventions

self-management

one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed

Intervention Type: OTHER

Control

Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• having a first ever stroke, by a physician, based on the WHO (1988) definition of stroke which is "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin"; ≥18 years of age; of sufficient cognition to participate: having a score of ≥24 points on mini-mental state examination (placing participants at matched mental status) ; are medically stable and; and are within the sub-acute to chronic phase of their rehabilitation (10 weeks to 6-months post stroke).

Exclusion Criteria

• Participants will be excluded if they have serious medical conditions such as HIV/AIDS or TB, which could additionally affect the outcomes evaluated in this study. Participants with depression, having recurrent stroke, still receiving in inpatient rehabilitation, with cognitive or receptive language difficulties and are unable to comprehend the intervention will be excluded.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Western Cape

OTHER

Sponsor Role: lead

Responsible Party

Reham Nasir

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Reham Nasir, MSc

Role: CONTACT

3608175@myuwc.ac.za

+27613756412

Anthea Rhoda, Professor

Role: CONTACT

arhoda@uwc.ac.za

+27827757748

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Other Identifiers

BM17/2/7

Identifier Type: -

Identifier Source: org_study_id