Title: Chronic Headache Education and Self-management Study (CHESS)
Funder: Department of Health and Social Care

Abstract: Background Headache disorders are a major cause of pain and disability. Chronic headache, defined as at least 15 headache days per month for at least three months, is the major cause of this. The commonest chronic headache disorders are tension type (TTH), migraine, and medication overuse headaches (MOH). TTH and migraine headaches are primary headaches. MOH is a secondary headache that can develop in people taking headache remedies on more than 10-15 days per month. Self-management support programmes have an established place in the management of a range of chronic diseases.[1-3] NICE, when developing headache guidelines, did not find any useable evidence on the use of education and self-management programmes for the treatment of chronic headaches and recommended further research. We will need to develop a structured diagnostic interview that will allow non-expert clinicians to distinguish and diagnose the three main, sometimes coexisting, common chronic headache types. Work is needed to select the most appropriate patient reported outcomes for our trial. Work is needed to develop a combined intervention for chronic headaches. This will need to include a tailored educational component, focussed on the use of medication, alongside a self-management support element based on cognitive behavioural principles which, amongst other things, will address illness beliefs. Aim To develop and test a support programme consisting of tailored education and generic components for people living with chronic headache. Objectives To develop and test strategies for recruiting people living with chronic headache from primary care To develop and evaluate a brief diagnostic interview to support diagnosis for people living with chronic headaches, focussing on the diagnosis of the three common chronic headache disorders; migraine, TTH and MOH, To develop and pilot an education a new self-management support intervention for the management of common chronic headache disorders (migraine, TTH, MOH) that is both theoretically informed and based on best available empirical evidence. To select most appropriate patient reported outcome measures for CHESS. To run a pragmatic randomised controlled trial, including an economic evaluation, of the CHESS intervention. To run formative and summative process evaluations of both the trial and the intervention Proposed research We propose six workstreams, each of which will address one of our objectives. We will develop and test strategies to identify people living with chronic headache from general practice consultation records. We will recruit around 170 participants from six &ndash; eight practices as a sampling frame for our exploratory studies (workstreams 2-4). To improve diagnosis of headache type we will develop a structured diagnostic interview for use by non-specialist clinicians. We will review existing literature on diagnostic tools, seek expert opinion, and confer with patient partners to develop a prototype diagnostic interview. In our feasibility population we will test the validity of the diagnostic interview by using expert clinicians diagnoses based on transcripts of the interviews. Informed by multiple new systematic reviews, and current best practice, we will develop a new intervention. We anticipate this will consist of a diagnostic interview that will inform personalised advice on headache management, including use of medication, plus a generic headache group self-management support programme. This self-management support programme will draw on theories of behaviour change. To pilot, and evaluate, the programme we will run it with around 50 people with chronic headaches. We will do a systematic review, and an interview study to inform a consensus meeting to select patient reported outcomes. We will evaluate the performance of candidate measures in our feasibility sample. To measure short term outcomes we will use a smart phone based data collection system. We will run a trial of our intervention with 500-700 participants with chronic headache. We will recruit from 20-40 general practice in Coventry and Warwickshire and north east London. Follow up will be for one year. Primary outcome will be headache related quality of life. Secondary outcomes are likely to include, headache days, mood, wellbeing, overall health related quality of life, social activity, and days lost from normal activities. We will conduct a parallel health economic evaluation. We will run a formative process evaluation informing the development of the intervention, the trial processes and its protocol over the first half of the project. In the second half of the project we will run a summative process evaluation of the implementation of the trial. Dissemination We will produce conventional academic papers and present our findings at key national and international conferences. All our academic outputs will be open access. We will, with help from our charity partners, make the main result available to patients in a user friendly form (and feed them back to our participants). We will disseminate our diagnostic interview and our intervention to the clinical community. We will provide training for those who wish to use our diagnostic interview or implement the programme.

Lay abstract: Chronic headache, that is headache occurring on 15 or more days per month for more than three months, is a common problem, affecting around one in 30 of the population. There are three main types of chronic headache; migraine, tension type and medication overuse. There is very little information on the use of non-drug treatments or how to support people to manage their chronic headaches better (supported self-management). We want to develop and test a self-management support programme for people living with chronic headache comprising of individually tailored and generic components (the CHESS intervention). The programme will draw on the experience of people with chronic headaches to identify both what sort of interventions would be acceptable and what would be a meaningful benefit from the intervention. We anticipate that our intervention will consist of a four-stage programme; 1) self-completed diagnostic diary, 2) diagnostic and educational interview with a nurse including tailored advice about medication use, 3) an intense generic headache self-management course with lay and professional joint leaders, 4) followed by an on-going telephone/e-mail support programme. The difficulty patients and non-specialist doctors have in diagnosing headaches appropriately can be a barrier to effective tailoring of treatment. This programme, therefore, differs from most chronic disease self-management support interventions because of the need to diagnose headache type so that tailored advice can be offered. Improved diagnosis will support the targeting of medications for headache; specifically the use of drugs to prevent the onset of migraine attacks, allow identification of those who have, or who are at risk of developing, medication overuse headache, and identify those who need advice on the avoidance of specific triggers that can precipitate a migraine headache. Within the programme we will have six workstreams Piloting study recruitment processes (recruitment feasibility) Developing a brief diagnostic interview to support accurate diagnosis of people with common chronic headache disorders; migraine, chronic tension type headache and medication overuse headache Developing an education and self-management support intervention for the management of common chronic headache disorders Choosing the most appropriate patient reported outcomes for the main trial Running a randomised controlled trial and parallel economic evaluation of the CHESS intervention To evaluate the processes needed to develop and deliver the trial and how the intervention works within the trial The final outputs from this programme will be a much improved understanding of how to run studies of intervention for chronic headaches, an approach to improving the diagnosis of chronic headaches, information on the measurement of outcomes for people with chronic headaches, and a randomised controlled trial, with a cost-effectiveness study, of the CHESS intervention.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: NEUROLOGICAL