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

Stroke Clinical Trial

Official title:

A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648750
• Other study ID #: 177976
• Status: Completed
• Phase: N/A
• First received: December 24, 2015
• Last updated: January 6, 2016
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jenny Freeman

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Stroke Self-Efficacy Scale at 6 weeks		6 weeks	No
Secondary	Change from baseline Modified Rivermead Mobility Index at 6 weeks	Functional mobility	6 weeks	No
Secondary	Change from baseline SIPSO at 6 weeks	social integration	6 weeks	No
Secondary	Change from baseline EQ5D at 6 weeks	health-related quality of life	6 weeks	No
Secondary	Change from baseline PHQ-9 at 6 weeks	depression	6 weeks	No