POSITIF POst Stroke Intervention Trial In Fatigue
Research type
Research Study
Full title
POSITIF POst Stroke Intervention Trial In Fatigue. A randomised multicentre trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue
IRAS ID
235209
Contact name
Gillian E Mead
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Stroke affects 150 000 people per year in the United Kingdom and is a leading cause of disability in the community. Fatigue affects at least a third of stroke survivors and is a major cause of impaired quality of life. It is a priority for research amongst stroke survivors, researchers and clinicians.
Fatigue is linked with being less physically active, having a low mood or anxiety, and sleeping poorly.
We have developed a cognitive-behavioural intervention which consists of seven telephone calls with a nurse over a 4 month period. The nurse will work through a manual with the stroke survivor and aim to increase activity, improve mood, address any negative beliefs and improve sleep.
Stroke survivors who are between 3 months and 2 years after their stroke will be invited to participate. Those with major depression or major anxiety will not be recruited. Those with fatigue will then complete some questionnaires about their quality of life, and will be randomly allocated to the intervention or to information only. If the stroke survivor has access to the internet, they will complete the questionnaires on-line. At the end of the intervention and then at six months after recruitment, they will complete some further questionnaires.
We aim to recruit at least 300 patients. If the intervention does improve fatigue, it will be rolled out within the NHS.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0159
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion