Back to resultsStroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bridges self-management programme
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring self-management, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of new stroke
- Being referred to the ESD service
- Medically stable
- Able to give informed consent
- Can follow a two-stage command
Exclusion Criteria:
- Being discharged to a care home
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rehabilitation Assistant
Therapist
Arm Description
Bridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period.
Bridges stroke self-management programme. Delivered by registered stroke therapists (Occupational therapists or physiotherapists). Participants will receive a minimum of 4 sessions over a 4-6 week period.
Outcomes
Primary Outcome Measures
Change from baseline Stroke Self-Efficacy Scale at 6 weeks
Secondary Outcome Measures
Change from baseline Modified Rivermead Mobility Index at 6 weeks
Functional mobility
Change from baseline SIPSO at 6 weeks
social integration
Change from baseline EQ5D at 6 weeks
health-related quality of life
Change from baseline PHQ-9 at 6 weeks
depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02648750
Brief Title
Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
Official Title
A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jenny Freeman
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. Half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.
Detailed Description
Supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. Barriers to implementation include time and resource. The feasibility of using the Bridges Stroke Self-Management Programme within an Early Supported Discharge Service and delivery by Rehabilitation Assistants is unknown.
The aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of Bridges delivered by rehabilitation assistants within an Early Supported Discharge Service.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
self-management, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation Assistant
Arm Type
Experimental
Arm Description
Bridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period.
Arm Title
Therapist
Arm Type
Active Comparator
Arm Description
Bridges stroke self-management programme. Delivered by registered stroke therapists (Occupational therapists or physiotherapists).
Participants will receive a minimum of 4 sessions over a 4-6 week period.
Intervention Type
Behavioral
Intervention Name(s)
Bridges self-management programme
Intervention Description
The Bridges self-management programme is based on self-efficacy principles. It includes a Bridges stroke workbook consisting of stroke survivors' experiences and strategies, with space to record and reflect on personal goals and achievements, which the practitioner will work through with the participant. The practitioner will also used strategies based on key principles of self-management during interactions with patients.
Primary Outcome Measure Information:
Title
Change from baseline Stroke Self-Efficacy Scale at 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Modified Rivermead Mobility Index at 6 weeks
Description
Functional mobility
Time Frame
6 weeks
Title
Change from baseline SIPSO at 6 weeks
Description
social integration
Time Frame
6 weeks
Title
Change from baseline EQ5D at 6 weeks
Description
health-related quality of life
Time Frame
6 weeks
Title
Change from baseline PHQ-9 at 6 weeks
Description
depression
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of new stroke
Being referred to the ESD service
Medically stable
Able to give informed consent
Can follow a two-stage command
Exclusion Criteria:
Being discharged to a care home
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Freeman, PhD
Organizational Affiliation
Plymouth University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
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