Usual care and a self-management support programme versus usual care and a relaxation programme for people living with chronic headache disorders: a randomised controlled trial protocol (CHESS)
Kirstie Haywood,
Martin Underwood,
Stavros Petrou,
Frances Griffiths,
Stephanie Taylor,
Sandra Eldridge,
Hema Mistry,
Dipesh Mistry,
Harbinder Kaur Sandhu,
Dawn Carnes,
Vivien P Nichols,
David R Ellard,
Rachel Potter,
Felix Achana,
Siew Wan Hee,
Tamar Pincus,
Kimberley Stewart,
Manjit Matharu
Affiliations
Kirstie Haywood
Warwick Research in Nursing, University of Warwick, Coventry, UK
Martin Underwood
Warwick Medical School, Coventry, UK
Stavros Petrou
Nuffield Department of Primary Care and Health Science, Oxford University, Oxford, UK
Frances Griffiths
Warwick Medical School, University of Warwick, Coventry, UK
Stephanie Taylor
2 Wolfson Institute of Population Health, Queen Mary University of London, London, UK
Sandra Eldridge
professor of biostatistics
Hema Mistry
1 Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
Dipesh Mistry
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
Harbinder Kaur Sandhu
Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK
Dawn Carnes
Wolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Vivien P Nichols
Clinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UK
David R Ellard
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
Rachel Potter
Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
Felix Achana
Warwick Medical School, University of Warwick, Coventry, UK
Siew Wan Hee
Warwick Medical School, University of Warwick, Coventry, UK
Tamar Pincus
Psychology, Royal Hollaway University of London, London, UK
Kimberley Stewart
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK
Manjit Matharu
Headache Group, UCL Institute of Neurology and The National Hospital for Neurology and Neurosurgery, London, UK
Introduction Chronic headaches are poorly diagnosed and managed and can be exacerbated by medication overuse. There is insufficient evidence on the non-pharmacological approaches to helping people living with chronic headaches.Methods and analysis Chronic Headache Education and Self-management Study is a pragmatic randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management education support programme on top of usual care for patients with chronic headaches against a control of usual care and relaxation. The intervention is a 2-day group course based on education, personal reflection and a cognitive behavioural approach, plus a nurse-led one-to-one consultation and follow-up over 8 weeks. We aim to recruit 689 participants (356 to the intervention arm and 333 to the control) from primary care and self-referral in London and the Midlands. The trial is powered to show a difference of 2.0 points on the Headache Impact Test, a patient-reported outcome measure at 12 months post randomisation. Secondary outcomes include health related quality of life, self-efficacy, social activation and engagement, anxiety and depression and healthcare utilisation. Outcomes are being measured at 4, 8 and 12 months. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained.Ethics and dissemination This trial will provide data on effectiveness and cost-effectiveness of a self-management support programme for chronic headaches. The results will inform commissioning of services and clinical practice. North West – Greater Manchester East Research Ethics Committee have approved the trial. The current protocol version is 3.6 date 7 March 2019.Trial registration number ISRCTN79708100.
