Chronic Headache Education and Self-management Study (CHESS) – a study of the clinical and cost effectiveness of an education and self-management intervention for people with chronic headache
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 689
研究概览
简要总结
2019 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/30744571 feasibility results 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/30885120 intervention development (added 20/03/2019) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32284387/ main trial protocol (added 15/02/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33942667/ comparative evaluation (added 05/05/2021) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34796815/ experiences of patient and public involvement (added 31/10/2022) 2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31164158/ process evaluation protocol (added 31/10/2022) 2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/36609224/ Process evaluation results (added 09/01/2023) 2023 Results article in https://doi.org/10.1212/wnl.0000000000201518 (added 05/09/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38745132/ post-hoc secondary analyses not specified in the original statistical analysis plan (added 20/05/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39095730/ Qualitative interviews conducted during the CHESS study (added 06/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able and willing to comply with the study procedures and provision of written informed consent
- •2. Aged 18 years or above
- •3. Living with chronic headache; defined as headache for 15 or more days per month for at least three months.
- •4. Result of nurse classification interview confirms headache type to be definite or probable chronic migraine, or chronic tension type headache, and/or medication overuse headache
- •5. Fluent in written and spoken English
排除标准
- •1. Unable to attend treatment programme
- •2. No access to a telephone
- •3. Has an underlying serious psychiatric or psychological disorder that precludes participation in the group intervention
- •4. Known secondary cause of headache other than medication overuse headache; e.g. primary or secondary brain tumour
- •5. Is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial