Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Daniel Hind, Sarah J Drabble, Madelynne A Arden, Laura Mandefield, Simon Waterhouse, Chin Maguire, Hannah Cantrill, Louisa Robinson, Daniel Beever, Alexander J Scott, Sam Keating, Marlene Hutchings, Judy Bradley, Julia Nightingale, Mark I Allenby, Jane Dewar, Pauline Whelan, John Ainsworth, Stephen J Walters, Alicia O'CathainMartin J Wildman

Research output: Contribution to journalArticle

4 Citations (Scopus)
147 Downloads (Pure)

Abstract

BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.

METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.

PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.

INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).

OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).

RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.

CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.

TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

Original languageEnglish
Pages (from-to)77
JournalBMC Pulmonary Medicine
Volume19
Issue number1
DOIs
Publication statusPublished - 11 Apr 2019

Fingerprint Dive into the research topics of 'Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study'. Together they form a unique fingerprint.

  • Cite this

    Hind, D., Drabble, S. J., Arden, M. A., Mandefield, L., Waterhouse, S., Maguire, C., Cantrill, H., Robinson, L., Beever, D., Scott, A. J., Keating, S., Hutchings, M., Bradley, J., Nightingale, J., Allenby, M. I., Dewar, J., Whelan, P., Ainsworth, J., Walters, S. J., ... Wildman, M. J. (2019). Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC Pulmonary Medicine, 19(1), 77. https://doi.org/10.1186/s12890-019-0834-6