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- Title
Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study.
- Authors
Hind, Daniel; Drabble, Sarah J.; Arden, Madelynne A.; Mandefield, Laura; Waterhouse, Simon; Maguire, Chin; Cantrill, Hannah; Robinson, Louisa; Beever, Daniel; Scott, Alexander J.; Keating, Sam; Hutchings, Marlene; Bradley, Judy; Nightingale, Julia; Allenby, Mark I.; Dewar, Jane; Whelan, Pauline; Ainsworth, John; Walters, Stephen J.; O'Cathain, Alicia
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.<bold>Participants: </bold>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.<bold>Interventions: </bold>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).<bold>Outcomes: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.<bold>Trial Registration: </bold>ISRCTN13076797 . Prospectively registered on 07/06/2016.
- Subjects
CYSTIC fibrosis; FEASIBILITY studies; SEMI-structured interviews; DRUGS; ADULTS
- Publication
BMC Pulmonary Medicine, 2019, Vol 19, Issue 1, pN.PAG
- ISSN
1471-2466
- Publication type
journal article
- DOI
10.1186/s12890-019-0834-6