Edinburgh Clinical Trials

About the Trial

The POSITIF Trial is a non-commercial trial sponsored by the University of Edinburgh and NHS Lothian and is funded by a research grant from Chest, Heart and Stroke Scotland (CHSS)

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. 

 

Meet the POSITIF therapists

M Couser POSITIF therapist

Mandy Couser

Mandy has been working as Stroke Research Nurse for in the Research and Development office for NHS Fife for 3 years.

As a stroke research nurse, Mandy’s main role is identify potential patients to see if they are eligible for trials to help provide evidence based research for driving improvement and outcomes.  Recruiting patients to trials results in a number of tasks including randomising, obtaining consent from the patients and relatives to participate, laboratory specimen collection and processing, data collection, electronic case reporting completion, site file maintenance, safety reporting.  There is also the need to coordinate patient follow-up visits and to have communications with study centres.

Mandy has a particular clinical interest in all areas of stroke and stroke care. 

 

 

 

 

 

 

 

 

 

 

 

 

Allan MacRaild

A MacRaild

Allan has been working as the Lead Stroke Research Nurse for the EMERGE team (Emergency Medicine Research Group Edinburgh) in NHS Lothian since April 2018. 

Allan leads the Stroke research nurse team and works closely with clinical and research colleagues in the Stroke Unit and Emergency Dept.  He co-ordinates the stroke research portfolio which encompasses a dynamic range of trials and studies.

Allan has particular clinical interests in stroke, delirium, new healthcare technology and compassionate care.