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Neurology
Protocol
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)
  1. Shilpa Patel1,
  2. Felix Achana2,
  3. Dawn Carnes3,
  4. Sandra Eldridge3,
  5. David R Ellard1,
  6. Frances Griffiths4,
  7. Kirstie Haywood4,
  8. Siew Wan Hee2,
  9. Dipesh Mistry1,
  10. Hema Mistry5,
  11. Vivien P Nichols1,
  12. Stavros Petrou2,
  13. Tamar Pincus6,
  14. Rachel Potter1,
  15. Harbinder Kaur Sandhu1,
  16. Kimberley Stewart1,
  17. Stephanie Taylor3,
  18. Martin Underwood1,
  19. Manjit Matharu7
  1. 1Warwick Medical School, Clinical Trials Unit, University of Warwick, Coventry, UK
  2. 2Warwick Medical School, University of Warwick, Coventry, UK
  3. 3Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
  4. 4Warwick Medical School, Division of Health Sciences, University of Warwick, Coventry, UK
  5. 5Warwick Medical School, Warwick Evidence, University of Warwick, Coventry, UK
  6. 6Department of Psychology, Royal Holloway University of London, Egham, UK
  7. 7University College London Queen Square Institute of Neurology and The National Hospital for Neurology and Neurosurgery, London, UK
  1. Correspondence to Dr Shilpa Patel; shilpa.patel{at}warwick.ac.uk

Abstract

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.

  • chronic headache
  • tension type headache
  • migraine
  • self-management
  • primary care
  • study protocol
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-033520

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    Footnotes

    • Twitter @DrShilpaPatel, @DrHSandhu

    • Contributors SP - study concept and design, wrote the first draft of the manuscript and finalised the manuscript for submission. FA, DC, SE, DE, FG, KH, SWH, DM, HM, VN, SPe, TP, RP, HS, SJT, KW, MSM - study concept and design, provided critical revisions to the manuscript. MU – conceived the original study design and supported writing of the first draft of the manuscript. DC, SE, DE, FG, KH, SWH, HM, SPe, TP, HS, SJT, MU, MSM - original grant holders.

    • Funding This research was funded by the NIHR Programme Grants for Applied Research programme (RP-PG- 1212-20018).

    • Disclaimer The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service, the National Institute for Health Research (NIHR) or the Department of Health.

    • Competing interests MU is a director and shareholder of Clinvivo Ltd. Use of this company was specified in original application for funding to NIHR. MU has recused himself from all discussion regarding the use of the app in this study. All contracting processes have been in accord with University of Warwick financial regulations. MU was chair of the National Institute for Health and Care Excellence accreditation advisory committee until March 2017 for which he received a fee. He is chief investigator or coinvestigator on multiple previous and current research grants from the UK NIHR, Arthritis Research UK and is a coinvestigator on grants funded by Arthritis Australia and Australian NHMRC. He has received travel expenses for speaking at conferences from the professional organisations hosting the conferences. He is part of an academic partnership with Serco Ltd related to return to work initiatives. He is an editor of the NIHR journal series and a member of the NIHR Journal Editors group for which he receives a fee. He has published multiple papers on chronic pain some of which are referenced in this paper. MM serves on the advisory board for Allergan, Medtronic, Novartis and TEVA and has received payment for the development of educational presentations from Allergan, electroCore, Medtronic, Novartis and TEVA. ShP and HKS are directors of Health Psychology Services Ltd, which in part provides psychological treatments for those with chronic pain.

    • Patient consent for publication Not required.

    • Ethics approval Ethics approval was given on the 17 February 2017 by North West – Greater Manchester East Research Ethics Committee (REC REF: 16/NW/0890). Written consent was taken for participation.

    • Provenance and peer review Not commissioned; externally peer reviewed.