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Clinical Trial Summary

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.

Clinical Trial Description

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

- Does the intervention improve fatigue at 4 months (i.e. immediately after the end of the intervention)?

- Does the intervention improve self-reported mood at 4 months and 6 months? This will be assessed using Patient Health Questionnaire (PHQ-9) (16) and the Generalised Anxiety Disorder (GAD7) (17). At 6 months we will also enquire whether antidepressants or anxiolytics have been prescribed.

- Does the intervention improve stroke specific quality of life including patient reported social participation? This will be assessed using the Modified Short Form of the Stroke Impact Scale (18).

- What is the cost of the intervention, and what is the quality of life adjusted life years (QUALYS)? To assess QUALYS, we will use the Euroquol 5D (5 level version) (21).

- Has the patient returned to work? If so are they working the same hours as prestroke?


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

- PHQ-9 and GAD-7 (4 months and 6 months after randomisation).

- Modified Short Form of the Stroke Impact Scale (6 months after randomisation) (18).

- At 4 months and 6 months after randomisation: The EuroQol (EQ-5D-5L) to provide an overall measure of health related quality of life (HRQOL) and to allow a health economic analysis based on quality adjusted life years ((20)). As repeated measures of the EQ-5D-5L are required for assessment of QUALYS; this will be done at baseline, 4 months and 6 months.

- Health costs (Between randomisation and 6 months) 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). This will enable us to perform a health economic analysis which will tell us how much the intervention costs, whether there are savings in usage of health/social care, and what QUALYS are associated with the intervention.

- We will ask the patient to list their medication. We will note any new prescriptions of anxiolytics or antidepressants ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03551327
Study type Interventional
Source University of Edinburgh
Contact Professor Gillian Mead, MB BChi MA MD FRCP
Phone +441316519909
Status Not yet recruiting
Phase N/A
Start date August 6, 2018
Completion date December 31, 2021