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)
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...
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/4/e033520.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Kirstie Haywood |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-52dc0cd345d149b68bc01c8e0103a5e6 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-52dc0cd345d149b68bc01c8e0103a5e62024-12-03T20:40:08ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-033520Usual 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 Haywood0Martin Underwood1Stavros Petrou2Frances Griffiths3Stephanie Taylor4Sandra Eldridge5Hema Mistry6Dipesh Mistry7Harbinder Kaur Sandhu8Dawn Carnes9Vivien P Nichols10David R Ellard11Rachel Potter12Felix Achana13Siew Wan Hee14Tamar Pincus15Kimberley Stewart16Manjit Matharu17Warwick Research in Nursing, University of Warwick, Coventry, UKWarwick Medical School, Coventry, UKNuffield Department of Primary Care and Health Science, Oxford University, Oxford, UKWarwick Medical School, University of Warwick, Coventry, UK2 Wolfson Institute of Population Health, Queen Mary University of London, London, UKprofessor of biostatistics1 Warwick Clinical Trials Unit, University of Warwick, Coventry, UKWarwick Clinical Trials Unit, University of Warwick, Coventry, UKClinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UKWolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKClinical Trials Unit, University of Warwick Warwick Medical School, Coventry, UKWarwick Clinical Trials Unit, University of Warwick, Coventry, UKClinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UKWarwick Medical School, University of Warwick, Coventry, UKWarwick Medical School, University of Warwick, Coventry, UKPsychology, Royal Hollaway University of London, London, UKWarwick Clinical Trials Unit, University of Warwick, Coventry, UKHeadache Group, UCL Institute of Neurology and The National Hospital for Neurology and Neurosurgery, London, UKIntroduction 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.https://bmjopen.bmj.com/content/10/4/e033520.full |
| spellingShingle | 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 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/4/e033520.full |
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