Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial

Authors

Martin J. Wildman, Sheffield Teaching Hospitals NHS Foundation Trust
CFHealthHub Study Team
Alicia O’Cathain, University of Sheffield
Chin Maguire, University of Sheffield
Madelynne A. Arden, Sheffield Hallam University
Marlene Hutchings, Sheffield Teaching Hospitals NHS Foundation Trust
Judy Bradley, Queen's University Belfast
Stephen J. Walters, University of Sheffield
Pauline Whelan, University of Manchester
John Ainsworth, University of Manchester
Iain Buchan, University of Manchester
Laura Mandefield, University of Sheffield
Laura Sutton, University of Sheffield
Paul Tappenden, University of Sheffield
Rachel A. Elliott, University of Manchester
Zhe Hui Hoo, Sheffield Teaching Hospitals NHS Foundation Trust
Sarah J. Drabble, University of Sheffield
Daniel Beever, University of Sheffield
H. Cantrill
J. Nicholl
S. Michie
S. Waterhouse
L. Robinson
A. Scott, Peninsula Medical School
S. Antrobus
E. Lumley
A. N. Biz
D. Hind
C. Orchard
E. Nash

Abstract

Introduction Recurrent pulmonary exacerbations lead to progressive lung damage in cystic fibrosis (CF). Inhaled medications (mucoactive agents and antibiotics) help prevent exacerbations, but objectively measured adherence is low. We investigated whether a multi-component (complex) self-management intervention to support adherence would reduce exacerbation rates over 12 months. Methods Between October 2017 and May 2018, adults with CF (aged ≥16 years; 19 UK centres) were randomised to the intervention (data-logging nebulisers, a digital platform and behavioural change sessions with trained clinical interventionists) or usual care (data-logging nebulisers). Outcomes included pulmonary exacerbations (primary outcome), objectively measured adherence, body mass index (BMI), lung function (FEV₁) and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Analyses were by intent to treat over 12 months. Results Among intervention (n=304) and usual care (n=303) participants (51% female, median age 31 years), 88% completed 12-month follow-up. Mean exacerbation rate was 1.63/year with intervention and 1.77/year with usual care (adjusted ratio 0.96; 95% CI 0.83 to 1.12; p=0.64). Adjusted mean differences (95% CI) were in favour of the intervention versus usual care for objectively measured adherence (9.5% (8.6% to 10.4%)) and BMI (0.3 (0.1 to 0.6) kg/m²), with no difference for %FEV₁ (1.4 (−0.2 to 3.0)). Seven CFQ-R subscales showed no between-group difference, but treatment burden reduced for the intervention (3.9 (1.2 to 6.7) points). No intervention-related serious adverse events occurred. Conclusions While pulmonary exacerbations and FEV₁ did not show statistically significant differences, the intervention achieved higher objectively measured adherence versus usual care. The adherence difference might be inadequate to influence exacerbations, though higher BMI and lower perceived CF treatment burden were observed.

DOI

10.1136/thoraxjnl-2021-217594

Publication Date

2022-01-01

Publication Title

Thorax

Volume

77

Issue

5

ISSN

0040-6376

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

First Page

461

Last Page

469

Recommended Citation

Wildman, M., CFHealthHub Study Team., O’Cathain, A., Maguire, C., Arden, M., Hutchings, M., Bradley, J., Walters, S., Whelan, P., Ainsworth, J., Buchan, I., Mandefield, L., Sutton, L., Tappenden, P., Elliott, R., Hoo, Z., Drabble, S., Beever, D., Cantrill, H., Nicholl, J., Michie, S., Waterhouse, S., Robinson, L., Scott, A., Antrobus, S., Lumley, E., Biz, A., Hind, D., Orchard, C., & Nash, E. (2022) 'Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial', Thorax, 77(5), pp. 461-469. Available at: https://doi.org/10.1136/thoraxjnl-2021-217594