An interventional study of Experimental: Intervention plus information and Active Comparator: Information only in Post-stroke Fatigue, sponsored by University of Edinburgh. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Treatment
The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months.
Primary Objective
Does a brief cognitive behavioural intervention for post-stroke fatigue lead to clinically relevant improvements in fatigue after 6 months? Fatigue will be assessed using the self-reported Fatigue Assessment Scale (FAS) which has been validated for use in stroke (14). This scale includes both mental and physical fatigue. Our data shows that a difference of approximately 5 points in FAS was associated with a clinically significant difference in people with stroke (15); the literature on stroke patients suggests that a difference in four points on the scale is considered to be 'clinically relevant'. We are conservatively basing our power calculations on a difference between groups of four points in the FAS.
Secondary Objectives
Endpoints
Primary Endpoint
The primary outcome is the Fatigue Assessment Scale (19) at 6 months after randomisation. The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke(14). A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
Secondary Endpoints
To answer our secondary objectives, we will collect the following outcome measures
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 76 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Answers 'Yes' to both the following questions about fatigue
Exclusion Criteria:
Participants in this arm will receive 6 telephone therapy sessions and 1 booster session. Participants will be followed up at 4 months and 6 months.
Behavioral: Experimental: Intervention plus information
Participants in this arm will receive information only. Participants will be followed up at 4 months and 6 months.
Other: Active Comparator: Information only
The intervention will include six sessions with a therapist, each separated by two weeks. During the two weeks between sessions, participants will work on the goals identified during the sessions. At the final session, the participants will agree how to maintain any improvements in fatigue. Then there will be a review phone call about 4-6 weeks after completion of the intervention, to check on progress and to offer ongoing encouragement to continue with the changes that have been made during the intervention. The intervention can be delivered by video conferencing as well as by phone.
Participants in this arm will be provided with information about fatigue.
Fatigue Assessment Scale (FAS)
The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke. A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
Time frame: 6 months after randomisation
PHQ-9
Questionnaire
Time frame: 4 months and 6 months after randomisation
GAD-7
Questionnaire
Time frame: 4 months and 6 months after randomisation
Modified Short Form of the Stroke Impact Scale
Questionnaire
Time frame: 6 months after randomisation
EuroQuol (EQ-5D-5L)
Questionnaire
Time frame: Baseline, 4 months and 6 months after randomisation
Health costs
For this health economic analysis, we will collect data on costs (visits to the GP, number of admissions to hospital, days in a care home, number of visits from social carers, cost of the therapist delivery time, cost of the supervision time from psychology/psychiatry).
Time frame: Between randomisation and 6 months
List of patient's medication
We will ask the patient to list their medication. We will note any new prescriptions of anxiolytics or antidepressants
Time frame: Between randomisation and 6 months
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Edinburgh