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)

<p><strong>Introduction:</strong> 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.</p> <p><strong>...

Full description

Bibliographic Details
Main Authors: Patel, S, Achana, F, Carnes, D, Eldridge, S, Ellard, DR, Griffiths, F, Haywood, K, Hee, SW, Mistry, D, Mistry, H, Nichols, VP, Petrou, S, Pincus, T, Potter, R, Sandhu, HK, Stewart, K, Taylor, S, Underwood, M, Matharu, M
Format: Journal article
Language:English
Published: BMJ 2020
_version_ 1797089993496199168
author Patel, S
Achana, F
Carnes, D
Eldridge, S
Ellard, DR
Griffiths, F
Haywood, K
Hee, SW
Mistry, D
Mistry, H
Nichols, VP
Petrou, S
Pincus, T
Potter, R
Sandhu, HK
Stewart, K
Taylor, S
Underwood, M
Matharu, M
author_facet Patel, S
Achana, F
Carnes, D
Eldridge, S
Ellard, DR
Griffiths, F
Haywood, K
Hee, SW
Mistry, D
Mistry, H
Nichols, VP
Petrou, S
Pincus, T
Potter, R
Sandhu, HK
Stewart, K
Taylor, S
Underwood, M
Matharu, M
author_sort Patel, S
collection OXFORD
description <p><strong>Introduction:</strong> 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.</p> <p><strong>Methods and analysis:</strong> 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.</p> <p><strong>Ethics and dissemination:</strong> 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.</p>
first_indexed 2024-03-07T03:12:03Z
format Journal article
id oxford-uuid:b486746a-bd8d-4a24-bf8c-8d3f4a6736de
institution University of Oxford
language English
last_indexed 2024-03-07T03:12:03Z
publishDate 2020
publisher BMJ
record_format dspace
spelling oxford-uuid:b486746a-bd8d-4a24-bf8c-8d3f4a6736de2022-03-27T04:26:48ZUsual 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)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b486746a-bd8d-4a24-bf8c-8d3f4a6736deEnglishSymplectic ElementsBMJ2020Patel, SAchana, FCarnes, DEldridge, SEllard, DRGriffiths, FHaywood, KHee, SWMistry, DMistry, HNichols, VPPetrou, SPincus, TPotter, RSandhu, HKStewart, KTaylor, SUnderwood, MMatharu, M<p><strong>Introduction:</strong> 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.</p> <p><strong>Methods and analysis:</strong> 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.</p> <p><strong>Ethics and dissemination:</strong> 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.</p>
spellingShingle Patel, S
Achana, F
Carnes, D
Eldridge, S
Ellard, DR
Griffiths, F
Haywood, K
Hee, SW
Mistry, D
Mistry, H
Nichols, VP
Petrou, S
Pincus, T
Potter, R
Sandhu, HK
Stewart, K
Taylor, S
Underwood, M
Matharu, M
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 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
work_keys_str_mv AT patels usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT achanaf usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT carnesd usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT eldridges usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT ellarddr usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT griffithsf usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT haywoodk usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT heesw usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT mistryd usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT mistryh usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT nicholsvp usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT petrous usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT pincust usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT potterr usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT sandhuhk usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT stewartk usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT taylors usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT underwoodm usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess
AT matharum usualcareandaselfmanagementsupportprogrammeversususualcareandarelaxationprogrammeforpeoplelivingwithchronicheadachedisordersarandomisedcontrolledtrialprotocolchess