StrokeNCT02648750
Stroke Self-Management Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service
A study testing Bridges self-management programme in people with Stroke, run by Jenny Freeman.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Bridges self-management programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of new stroke
- Being referred to the ESD service
- Medically stable
- Able to give informed consent
- Can follow a two-stage command
Who cannot join
- Being discharged to a care home
About this study
Official title: A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Bridges self-management programme
- Keywords
- self-management, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridges self-management programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Bridges self-management programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Stroke Self-Efficacy Scale at 6 weeks
Measured: Baseline and 6 weeks
Secondary outcomes (4)
Change from baseline Modified Rivermead Mobility Index at 6 weeks
Functional mobility
Measured: Baseline and 6 weeks
Change from baseline SIPSO at 6 weeks
social integration
Measured: Baseline and 6 weeks
Change from baseline EQ5D at 6 weeks
health-related quality of life
Measured: Baseline and 6 weeks
Change from baseline PHQ-9 at 6 weeks
depression
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Freeman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenny Freeman, University of Plymouth
- Investigators
- Jenny Freeman, PhD, Study director, Plymouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648750
- Sponsor's protocol ID
- 177976
- Status last verified
- Jul 2024
- First submitted
- 24 Dec 2015
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02648750
- Acronym / sponsor ID
- 177976
- Conditions
- Stroke
- Keywords
- self-management, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jenny FreemanUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Assistant | Experimental | Behavioral: Bridges self-management programmeBridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period. |
| Therapist | Active comparator | Behavioral: Bridges self-management programmeBridges 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of new stroke
- Being referred to the ESD service
- Medically stable
- Able to give informed consent
- Can follow a two-stage command
Key exclusion criteria (1 listed)
- Being discharged to a care home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridges self-management programmeThe 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. | Behavioural | Rehabilitation Assistant, Therapist |
Primary outcome
Change from baseline Stroke Self-Efficacy Scale at 6 weeks
Time frame: Baseline and 6 weeks
4 secondary outcomes
Change from baseline Modified Rivermead Mobility Index at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline SIPSO at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline EQ5D at 6 weeks
Time frame: Baseline and 6 weeks
Change from baseline PHQ-9 at 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Freeman, PhD study director
Plymouth University
Questions about this trial
What is this clinical trial studying?
A study testing Bridges self-management programme in people with Stroke, run by Jenny Freeman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Stroke Self-Efficacy Scale at 6 weeks (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.