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IMPACT study on intervening with a manualised package to achieve treatment adherence in people with tuberculosis: protocol paper for a mixed-methods study, including a pilot randomised controlled trial
- Source :
- BMJ Open, Stagg, HR, Abubakar, I, Campbell, CNJ, Copas, A, Darvell, M, Horne, R, Kielmann, K, Kunst, H, Mandelbaum, M, Pickett, E, Story, A, Vidal, N, Wurie, F & Lipman, M 2019, ' IMPACT study on intervening with a manualised package to achieve treatment adherence in people with tuberculosis: protocol paper for a mixed-methods study, including a pilot randomised controlled trial. ', BMJ Open . https://doi.org/10.1136/bmjopen-2019-032760
- Publication Year :
- 2019
- Publisher :
- BMJ Publishing Group, 2019.
-
Abstract
- IntroductionCompared with the rest of the UK and Western Europe, England has high rates of the infectious disease tuberculosis (TB). TB is curable, although treatment is for at least 6 months and longer when disease is drug resistant. If patients miss too many doses (non-adherence), they may transmit infection for longer and the infecting bacteria may develop resistance to the standard drugs used for treatment. Non-adherence may therefore risk both their health and that of others. Within England, certain population groups are thought to be at higher risk of non-adherence, but the factors contributing to this have been insufficiently determined, as have the best interventions to promote adherence. The objective of this study was to develop a manualised package of interventions for use as part of routine care within National Health Services to address the social and cultural factors that lead to poor adherence to treatment for TB disease.Methods and analysisThis study uses a mixed-methods approach, with six study components. These are (1) scoping reviews of the literature; (2) qualitative research with patients, carers and healthcare professionals; (3) development of the intervention; (4) a pilot randomised controlled trial of the manualised intervention; (5) a process evaluation to examine clinical utility; and (6) a cost analysis.Ethics and disseminationThis study received ethics approval on 24 December 2018 from Camberwell St. Giles Ethics Committee, UK (REC reference 18/LO/1818). Findings will be published and disseminated through peer-reviewed publications and conference presentations, published in an end of study report to our funder (the National Institute for Health Research, UK) and presented to key stakeholders.Trial registration numberNCT95243114Secondary identifying numbersUniversity College London/University College London Hospitals Joint Research Office 17/0726.National Institute for Health Research, UK 16/88/06.
- Subjects :
- medicine.medical_specialty
Tuberculosis
protocols & guidelines
Treatment adherence
Cost-Benefit Analysis
Population
Psychological intervention
Pilot Projects
Disease
law.invention
Medication Adherence
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Protocol
Medicine
Humans
030212 general & internal medicine
education
Respiratory Medicine
Drug Packaging
Randomized Controlled Trials as Topic
manuals
education.field_of_study
business.industry
General Medicine
medicine.disease
United Kingdom
tuberculosis
Infectious disease (medical specialty)
Family medicine
Quality of Life
business
030217 neurology & neurosurgery
pilot studies
Qualitative research
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 9
- Issue :
- 12
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....02b0c20b71449ef4d26536a09599b60a