StrokeRCASNCT03807284
Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial
A study testing A group psychosocial course in people with Stroke, run by University of Nottingham.
Trial summary
The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- A group psychosocial course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 31 Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of stroke within two years
- Discharged from all other rehabilitation therapies
- Not involved in trials of other psychological interventions
- Not previously attended an RCAS course
Who cannot join
- Score of <10 on the Barthel Index (sufficiently independent to cope in a group setting)
- Score <8 on the Sheffield Screening test for Acquired Language Disorders so that participants would be able to understand the materials being presented
- Unable to speak English
- Unable to give informed consent
About this study
Official title: Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.
The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.
Read the detailed description
The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. This feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.
- Conditions
- Stroke
- Being tested
- A group psychosocial course
- Keywords
- Feasibility, Confidence, group intervention, Psycho-social intervention, Stroke recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A group psychosocial courseBehavioural
Also called Regaining Confidence After Stroke Course
A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.
| Study group | Role | What they receive |
|---|---|---|
| A group psycho-social course | Experimental | The intervention group received a group psycho-social course, a 2 hour, weekly, eleven week intervention delivered by a health professional working in stroke and usual care. Receives: Behavioral: A group psychosocial course |
| Control Group | No intervention | Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruited to the trial
Number of participants recruited to the trial
Measured: One year recruitment period
Number of participants who completed the trial
Number of participants who completed the trial
Measured: End of Study
Secondary outcomes (5)
Mood
GHQ-30. Mood is measured using 30 questions, each with four response scores (0=better than usual) (1= about the same) (2 =Less well than usual) (3=Much less well than usual) maximum score is 90.
Measured: Baseline, 3 and 6 months follow up
Activity
Nottingham Extended Activity of Daily Living Scale. A ranked self-assessment of important activities after following a stroke. Scale is ranked from 0-22.
Measured: Baseline, 3 and 6 months follow up
Level of Confidence
A Confidence after Stroke (53 item) measure. This measure uses a Likert type format with four 'Likert type' responses, from zero to three depending on a positive or negative worded item. The highest achievable score of 159 indicating a high level of confidence.
Measured: Baseline, 3 and 6 months follow up
Coping
The COPE inventory (Coping Orientation for Problem Orientated Experiences) a 60 question measure which asks how participants deal with stress and what they do in stressful events. The inventory has 15 domains and a maximum score of 16 is achievable. A high score indicates more frequent use of the described coping strategy
Measured: Baseline, 3 and 6 months follow up
Carers strain
Carer Strain Index. The measure consists of 13 questions with yes or no answers. Highest score of 13 is achievable, where a high score indicates increased carer strain
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Apr 2013
- Primary completion31 Aug 2014
- Study completion31 Aug 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group two arm feasiblity randomised controlled trial with 1:1 allocation in a single centre, comparing eleven week RCAS Course in addition to usual care, to usual care alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807284
- Sponsor's protocol ID
- 12061
- Acronym
- RCAS
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.
- ClinicalTrials.gov ID
- NCT03807284
- Acronym / sponsor ID
- RCAS / 12061
- Conditions
- Stroke
- Keywords
- Feasibility, Confidence, group intervention, Psycho-social intervention, Stroke recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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.
The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.
Detailed description
The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. This feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group two arm feasiblity randomised controlled trial with 1:1 allocation in a single centre, comparing eleven week RCAS Course in addition to usual care, to usual care alone.
| Arm | Type | Receives |
|---|---|---|
| A group psycho-social course | Experimental | Behavioral: A group psychosocial courseThe intervention group received a group psycho-social course, a 2 hour, weekly, eleven week intervention delivered by a health professional working in stroke and usual care. |
| Control Group | No intervention | –Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical diagnosis of stroke within two years
- Discharged from all other rehabilitation therapies
- Not involved in trials of other psychological interventions
- Not previously attended an RCAS course
Key exclusion criteria (4 listed)
- Score of <10 on the Barthel Index (sufficiently independent to cope in a group setting)
- Score <8 on the Sheffield Screening test for Acquired Language Disorders so that participants would be able to understand the materials being presented
- Unable to speak English
- Unable to give informed consent
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 |
|---|---|---|
| A group psychosocial courseAlso: Regaining Confidence After Stroke CourseA 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke. | Behavioural | A group psycho-social course |
Primary outcome
Number of participants recruited to the trial
Time frame: One year recruitment period
Number of participants recruited to the trial
Number of participants who completed the trial
Time frame: End of Study
Number of participants who completed the trial
5 secondary outcomes
Mood
Time frame: Baseline, 3 and 6 months follow up
Activity
Time frame: Baseline, 3 and 6 months follow up
Level of Confidence
Time frame: Baseline, 3 and 6 months follow up
Coping
Time frame: Baseline, 3 and 6 months follow up
Carers strain
Time frame: Baseline, 3 and 6 months
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 25 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A group psychosocial course in people with Stroke, run by University of Nottingham.
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 4 inclusion and 4 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 25 Jan 2019. 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?
Number of participants recruited to the trial (time frame: One year recruitment period). The study lists 2 primary outcomes in all. 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 25 Jan 2019.