NCT03807284

Brief 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. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2013

Longer than P75 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

April 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

January 10, 2019

Last Update Submit

January 23, 2019

Conditions

Stroke

Keywords

FeasibilityConfidencegroup interventionPsycho-social interventionStroke recovery

Outcome Measures

Primary Outcomes (2)

  • Number of participants recruited to the trial

    Number of participants recruited to the trial

    One year recruitment period

  • Number of participants who completed the trial

    Number of participants who completed the trial

    End of Study

Secondary Outcomes (5)

  • Mood

    Baseline, 3 and 6 months follow up

  • Activity

    Baseline, 3 and 6 months follow up

  • Level of Confidence

    Baseline, 3 and 6 months follow up

  • Coping

    Baseline, 3 and 6 months follow up

  • Carers strain

    Baseline, 3 and 6 months

Study Arms (2)

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.

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.

Interventions

A group psychosocial courseBEHAVIORAL

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

Also known as: Regaining Confidence After Stroke Course
A group psycho-social course

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was masked to the intervention until the outcomes were complete.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 16, 2019

Study Start

April 1, 2013

Primary Completion

August 31, 2014

Study Completion

August 31, 2016

Last Updated

January 25, 2019

Record last verified: 2019-01