Warwick Medical School, Clinical Trials Unit, University of Warwick, Coventry, UK
Warwick Medical School, University of Warwick, Coventry, UK.
BMJ Open. 2020 Apr 12;10(4):e033520. doi: 10.1136/bmjopen-2019-033520.
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.
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.
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.
ISRCTN79708100.
慢性头痛的诊断和治疗效果不佳，且可能因药物滥用而加重。目前，针对帮助慢性头痛患者的非药物治疗方法，相关证据有限。
慢性头痛教育和自我管理研究是一项实用型随机对照试验，旨在检验在常规护理的基础上，为慢性头痛患者提供自我管理教育支持计划（实验组）与常规护理加放松疗法（对照组）相比的有效性和成本效益。实验组的干预措施为为期两天的小组课程，内容基于教育、个人反思和认知行为方法，外加护士主导的一对一咨询和八周随访。我们计划在伦敦和米德兰兹地区的初级保健和自我转诊中招募 689 名参与者（实验组 356 名，对照组 333 名）。试验的目的是在随机分组后 12 个月时，通过头痛影响测试（一种患者报告的结果测量工具）显示出 2.0 分的差异。次要结果包括健康相关生活质量、自我效能感、社会参与度、焦虑和抑郁以及医疗保健利用情况。结果将在 4、8 和 12 个月时进行测量。成本效益将用每增加一个质量调整生命年来表示。
本试验将提供有关慢性头痛自我管理支持计划的有效性和成本效益的数据。试验结果将为服务的委托和临床实践提供信息。西北-大曼彻斯特东研究伦理委员会已经批准了该试验。当前协议版本为 2019 年 3 月 7 日的 3.6 版。
ISRCTN79708100。
