Research Information Sheet for Practices

Study Title	CHESS - Chronic Headache Education and Self-management Study
Sponsor	University of Warwick
Funders	National Institute for Health Research Programme Grants for Applied Research
Chief Investigator	Professor Martin Underwood, Clinical Trials Unit, University of Warwick
Study design	Feasibility Study
Primary Study Aim & Objectives	The overall aim of the CHESS research programme is to develop and test a self-management support programme for people living with chronic headaches. The objectives of this feasibility study are: To test the feasibility of recruiting people living with chronic headache from primary care. To evaluate a brief diagnostic classification interview to support classification of the three common chronic headache disorders: migraine, tension type and medication overuse. To pilot and evaluate a new group self-management support intervention for the management of common chronic headache disorders To evaluate our proposed package of outcome measures To demonstrate the feasibility of doing a future randomised controlled trial of the clinical and cost-effective of the intervention
Practice target & study duration	Approximately 15-25 patients per practice dependent on list size. 6 months duration
Recruitment period	October 2015 to July 2016 (inclusive)
Summary of Eligibility Criteria (refer to Protocol for full criteria)	Inclusion criteria Aged ≥18 years with chronic headache; defined as headache for 15 or more days per month for at least three months. Fluent in written and spoken English. Exclusion criteria Has an underlying serious psychiatric or psychological disorder that precludes participation in a group intervention. Known secondary cause of headache other than medication overuse headache; e.g. primary or secondary brain tumour. Is currently participating in another headache trial. No access to a telephone.
Core Practice Activities	Run a database search, predetermined Read codes will be provided by the study team GP to check list of identified patients and remove any inappropriate patients Mail merge the identified list with the practice-headed patient invitation letter and mail to identified patients (postage costs will be covered by the study) Provide access to patient records for 3 month data collection of consultations, health service activity, and medication use related to headaches Report any serious adverse events (hospitals admissions / deaths)
Patient Involvement	Receive telephone call to confirm eligibility and explain study Provide written consent and complete postal questionnaires at baseline, 2 weeks and 3 months Complete an electronic diary of headache frequency, duration and severity (smartphone app or paper version available) weekly for three months Complete a telephone interview with a research nurse to classify headache type A subsample of patients will be asked to take part in qualitative interviews A subsample of participants will be asked to pilot the intervention and attend a short self-management support group for one week
Resources provided by the study team	Study team will provide each participating practice with all resources for the mail out, a study Site File and will update practices with any study amendments for the study duration Trial specific research nurse support and assistance from local CRN team
Reimbursement	NHS support costs will be available for the study

Study Flow Diagram