NCT02648750

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

December 24, 2015

Last Update Submit

July 2, 2024

Conditions

Keywords

self-managementrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Stroke Self-Efficacy Scale at 6 weeks

    Baseline and 6 weeks

Secondary Outcomes (4)

  • Change from baseline Modified Rivermead Mobility Index at 6 weeks

    Baseline and 6 weeks

  • Change from baseline SIPSO at 6 weeks

    Baseline and 6 weeks

  • Change from baseline EQ5D at 6 weeks

    Baseline and 6 weeks

  • Change from baseline PHQ-9 at 6 weeks

    Baseline and 6 weeks

Study Arms (2)

Rehabilitation Assistant

EXPERIMENTAL

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

Therapist

ACTIVE COMPARATOR

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

Interventions

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.

Rehabilitation AssistantTherapist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of new stroke
  • Being referred to the ESD service
  • Medically stable
  • Able to give informed consent
  • Can follow a two-stage command

You may not qualify if:

  • Being discharged to a care home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jenny Freeman, PhD

    Plymouth University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Reader in Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

December 24, 2015

First Posted

January 7, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share