Exploring the impact of modulators on physiotherapy (TEMPO study)
Research type
Research Study
Full title
Qualitative study to explore the impact of modulator drugs on attitudes and opinions towards physiotherapy and nebulised treatment in children and young people with cystic fibrosis.
IRAS ID
299610
Contact name
Malcolm Brodlie
Contact email
Sponsor organisation
Newcastle Joint Research Office
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Cystic fibrosis (CF) is an inherited multisystem disorder. Lung problems are the major cause of morbidity and premature mortality. A multidisciplinary approach to care is crucial and cornerstones of treatment include chest physiotherapy and nebulisers to clear secretions effectively and help prevent airway infection and inflammation.
However, such treatments are associated with a major burden on patients and families. In 2017 a James Lind priority setting exercise in CF research involving patients identified reducing treatment burden as the number one target.We have recently entered a welcome new era in CF care with the introduction of modulator drugs that address the underlying molecular problem in CF (rather than ameliorating downstream effects) and have been shown to be of major benefit to patients.
In this study we aim to investigate the opinions of children and young people with CF and their families or caregivers, along with multidisciplinary healthcare professionals, on the impact of CFTR modulator therapy and the need for and adherence with physiotherapy and nebulised treatments.
Potential participants will be identified by the study team and offered the chance to take part if they wish after reading the information sheet and having any questions answered. A semi-structured qualitative interview will be conducted and all responses will be treated anonymously.
The findings will provide insights in to the impact of treatment with modulator drugs on treatment burden, with special focus on chest physiotherapy and nebulisers, that will inform approaches to CF care in the post-modulator era and the most relevant questions to be addressed by future clinical research.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0210
Date of REC Opinion
4 Oct 2021
REC opinion
Further Information Favourable Opinion