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

HIND, Daniel, DRABBLE, Sarah J, ARDEN, Madelynne, 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 and WILDMAN, Martin J (2019). Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC Pulmonary Medicine, 19 (77).

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Official URL: https://bmcpulmmed.biomedcentral.com/articles/10.1...
Open Access URL: https://bmcpulmmed.biomedcentral.com/articles/10.1... (Published version)
Link to published version:: https://doi.org/10.1186/s12890-019-0834-6

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.

Item Type: Article
Uncontrolled Keywords: 1102 Cardiorespiratory Medicine and Haematology; Respiratory System
Identification Number: https://doi.org/10.1186/s12890-019-0834-6
SWORD Depositor: Symplectic Elements
Depositing User: Symplectic Elements
Date Deposited: 15 Apr 2019 16:33
Last Modified: 15 Apr 2019 16:33
URI: http://shura.shu.ac.uk/id/eprint/24458

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