CHESS Main Randomised Controlled Trial
Research type
Research Study
Full title
Chronic Headache Education and Self-management Study (CHESS)
IRAS ID
215304
Contact name
Martin Underwood
Contact email
Sponsor organisation
University of Warwick
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This trial is a trial comparing two groups; the first a self-management programme and the second a relaxation control for participants living with chronic headache. This is a randomised control trial whereby participants who consent to take part will be randomly allocated to one of the two groups. The overall aim is to test the effectiveness and cost effectiveness of our group self-management programme which targets.
The trial will be run in two locations (West Midlands and London). We will primarily recruit participants from GP practices. Within these practices we will search GP records to identify people who have consulted with headache disorders, or received prescriptions for migraine specific drugs in the preceding two years. However, many people with chronic headaches are self-managing, usually with over the counter preparations, and not consulting their general practitioner. We will, therefore, supplement recruitment by allowing self-referral to study for people, living locally to participating practices, who are living with chronic headaches. To facilitate this we will place posters in the waiting areas of participating practices and those pharmacies that mainly serve their population. We will also advertise this on our website. The clinical and cost effectiveness of the CHESS intervention will be compared to a best usual care package.
Participants will be asked to take part in a nurse classification interview which will allow us to classify their headache type. They will subsequently be randomly allocated to either group. Those in the self-management group will be invited to attend a two day group programme followed by a one to one appointment with the nurse. Participants will be asked to complete questionnaires at the start of the trial then at four, eight and 12 months thereafter.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
16/NW/0890
Date of REC Opinion
17 Feb 2017
REC opinion
Further Information Favourable Opinion