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Chronic headache education and self-management study (CHESS) - a mixed method feasibility study to inform the design of a randomised controlled trial

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White, Kimberley, Potter, Rachel, Patel, Shilpa, Nichols, Vivien P., Haywood, Kirstie L., Hee, Siew Wan, Mistry, Dipesh, Carnes, Dawn, Taylor, Stephanie S. J., Underwood, Martin and Matharu, Manjit S. (2019) Chronic headache education and self-management study (CHESS) - a mixed method feasibility study to inform the design of a randomised controlled trial. BMC Medical Research Methodology, 19 . 30. doi:10.1186/s12874-019-0672-5

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Official URL: https://doi.org/10.1186/s12874-019-0672-5

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Abstract

Background

Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS).

Methods

Participants were identified and recruited from general practices in the West Midlands of the UK. We developed a nurse - led chronic headache classification interview and assessed agreement with an interview with headache specialists. We developed and tested a group based education and self-management intervention to assess training and delivery receipt using observation, facilitator, and participant feedback. We explored the acceptability and relevance of PROMs using postal questionnaires, interviews and a smartphone app.

Results

Fourteen practices took part in the study and participant recruitment equated to 1.0/1,000 registered patients. Challenges to recruitment were identified. We did paired headache classification interviews. The level of agreement between nurse and doctor interviews was very good. We piloted the intervention in four groups with participants. Qualitative feedback from participants and facilitators helped refine the intervention including shortening the overall intervention and increasing the facilitator training time. Participants completed baseline questionnaires, measurement data quality, reliability and validity for headache specific and generic measures was acceptable.

Conclusion

This study indicated that recruiting people with chronic headache from primary care is feasible but challenging, our headache classification interview is fit for purpose, our study intervention is viable, and that our choice of outcome measures is acceptable to participants in a future randomised controlled trial (RCT).

Trial Registration:

ISRCTN, ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Migraine, Headache
Journal or Publication Title: BMC Medical Research Methodology
Publisher: BioMed Central Ltd.
ISSN: 1471-2288
Official Date: 11 February 2019
Dates:
DateEvent
11 February 2019Available
31 January 2019Accepted
Volume: 19
Article Number: 30
DOI: 10.1186/s12874-019-0672-5
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
R-PG-1212-20018[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
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