Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

University of Nottingham51 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants recruited to the trial

Time frame: One year recruitment period

Number of participants who completed the trial

Time frame: End of Study

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Baseline, 3 and 6 months follow up

Data from ClinicalTrials.gov

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