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

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; FEV 1 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 FEV 1 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...

Investigating the Temporal Relationships between Symptoms and Nebuliser Adherence in People with Cystic Fibrosis: A Series of N-of-1 Observations

“…The adherence data used in this study was recorded using the same method as previous work in the area [12]. Objective adherence to the eTrack®system (Pari GmbH, Stanberg, Germany) was recorded along with the patients' prescription.…”

“…Adherence to nebuliser treatments is poor [12] and there is a large difference between self-reported and objective adherence rates. Daniels et al [13] found that adults self-reported 80% adherence levels, which corresponded with an adherence rate of only 36% for this group when using objective nebuliser reports taken from the I-neb adaptive aerosol delivery (AAD) nebuliser system (Philips Respironics; Chichester, England).…”

“…When adherence is high, this has been found to have lower healthcare costs for both inpatient treatment and prescribed medications [17,18]. In 2013, it was estimated that CF patients treated in the UK by the National Health Service (NHS) spent 103,453 days receiving intravenous antibiotics [12]. One factor which can influence this perception of necessity is experiencing nonreinforcement as a result of taking medication (e.g., no noticeable reduction in their symptoms); if patients cannot feel it working, then they are less likely to perceive it as necessary.…”

Adult Care in Cystic Fibrosis

“…Maximizing adherence requires an honest and open relationship with the individual and flexibility from health care practitioners to understand what an individual can do and to help them prioritize their treatment program. 126 Chipped inhalers and nebulizers may provide valuable biofeedback and actual data to improve patient/health care team discussions. 127 The MDT pharmacist, physiotherapist, and psychologist can all make helpful contributions to facilitating the most efficient use of medicines in individual patients.…”

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation

“…28 29 In response, a complex intervention was developed to support inhaled medication adherence in PWCF. 30 This article presents the results of a process evaluation that was undertaken alongside a pilot randomised controlled trial (RCT), the objectives of which were to determine the feasibility of a full-scale RCT. 30 Here, we describe the resultant changes made to intervention procedures prior to that full-scale RCT.…”