Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

NCT ID: NCT03807284

Last Updated: 2019-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor was masked to the intervention until the outcomes were complete.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A group psycho-social course

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.

Group Type EXPERIMENTAL

A group psychosocial course

Intervention Type BEHAVIORAL

A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.

Control Group

Participants in the usual care control group will continue to receive all other services routinely available to them as is usual practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

A group psychosocial course

A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Regaining Confidence After Stroke Course

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Related Links

Access external resources that provide additional context or updates about the study.

http://eprints.nottingham.ac.uk/id/eprint/38848

Regaining Confidence after Stroke - a feasibility study. MPhil KE Hooban

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12061

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.