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Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service

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ClinicalTrials.gov Identifier: NCT02648750
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jenny Freeman, University of Plymouth

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Bridges self-management programme Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Rehabilitation Assistant
Bridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period.
Behavioral: Bridges self-management programme
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.

Active Comparator: Therapist

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.

Behavioral: Bridges self-management programme
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 Measures :
  1. Change from baseline Stroke Self-Efficacy Scale at 6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change from baseline Modified Rivermead Mobility Index at 6 weeks [ Time Frame: 6 weeks ]
    Functional mobility

  2. Change from baseline SIPSO at 6 weeks [ Time Frame: 6 weeks ]
    social integration

  3. Change from baseline EQ5D at 6 weeks [ Time Frame: 6 weeks ]
    health-related quality of life

  4. Change from baseline PHQ-9 at 6 weeks [ Time Frame: 6 weeks ]
    depression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648750


Sponsors and Collaborators
Jenny Freeman
Investigators
Study Director: Jenny Freeman, PhD Plymouth University

Responsible Party: Jenny Freeman, Reader in Physiotherapy and Rehabilitation, University of Plymouth
ClinicalTrials.gov Identifier: NCT02648750     History of Changes
Other Study ID Numbers: 177976
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jenny Freeman, University of Plymouth:
self-management
rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases