Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03551327 |
| Other study ID # |
AC17066 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 19, 2018 |
| Est. completion date |
July 31, 2021 |
Study information
| Verified date |
May 2024 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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?
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
- 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
