Parts of this section are reproduced or adapted with permission from Hind et al.41 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/. The text below includes minor additions and formatting changes to the original text.
Aim
The aim was to assess the feasibility of RCT procedures and the intervention.
Methods
Design
This was a pilot, open-label, parallel-group RCT with concurrent mixed-methods process evaluation. The pilot RCT has been reported in Hind et al.41 The qualitative research from the process evaluation has been reported in Drabble et al.42 and Hind et al.43
Randomised controlled trial
Participants were PWCF at two CF centres. Inclusion criteria: aged ≥ 16 years and on the CF registry. Exclusion criteria: post lung transplant or on the active list, unable to consent, or using dry-powder inhalers.
Qualitative research
Sarah J Drabble, Samuel Keating and Alexander Scott interviewed intervention (n = 14) and control (n = 5) participants, interventionists (n = 3 on two occasions) and CF team members (n = 5) at the two CF sites. See Work packages 2.1A and 2.1B: a qualitative study – understanding the illness perceptions and treatment beliefs of people with cystic fibrosis for Sarah J Drabble’s credentials and experience. Participants were identified from RCT records and sampled purposively in a similar way to WP 2.1. A total of 49 patients agreed to be approached for interview. We were unable to contact 14 patients and did not actively invite seven, leaving a sample of 28, among whom 23 consented. People declined because they were too busy, had withdrawn from the intervention or did not show up for the interview. Patients were interviewed mainly at home and staff in their workplace or by telephone. The patient sample comprised nine male and five female patients, aged 17–69 years, across all deprivation levels and had fewer people with low levels of adherence than we wanted. The topic guide was used in the process evaluation of the full RCT is shown in Report Supplementary Material 8. All interviews were audio-recorded and field notes were taken and these were analysed using NVivo. Interviews lasted between 11 and 102 minutes (mean 56 minutes).
Interventions
Central randomisation using a computer-generated pseudo-random list and random permuted blocks of varying sizes (2, 4 and 6), stratified by site and number of IVAB days in the previous 12 months (≤ 14 days and > 14 days) on a 1 : 1 allocation to (1) the intervention arm, which involved linking a nebuliser with data recording and transfer capability to a software platform and strategies to support self-management with trained interventionists (n = 32), or (2) the control arm, which involved typically face-to-face meetings every 3 months with the CF team (n = 32).
Outcomes and processes
Trial feasibility was defined as recruitment of > 48 participants (75% of target) in 4 months (pilot primary outcome), valid exacerbation data available for > 85% of those randomised (future RCT primary outcome), change in percentage of medication adherence (secondary outcome in future RCT), use of CFHealthHub and positive perceptions of the intervention from qualitative interviews.
Results
The pilot RCT recruited to target, randomising 33 participants to the intervention arm and 31 participants to the control arm during the 4-month period June to September 2016. At study completion (30 April 2017), 60 (94%) participants (intervention arm, n = 32; control arm, n = 28) contributed good-quality exacerbation data. Five serious adverse events occurred, none of which was related to the intervention. The process evaluation identified problems with data connectivity, which affected adherence data. The mean change in adherence was 10% (95% CI –5.2% to 25.2%) higher in the intervention arm. Data from CFHealthHub identified that interventionists delivered insufficient numbers of review sessions to identify and address low levels of motivation. Concentration on participant recruitment left site interventionists insufficient time for key intervention procedures.
In the qualitative interview study there was evidence of the expected behaviour change mechanisms of action. Mechanisms of action were similar to those associated with effective telehealth interventions for self-management support: relationships, visibility and fit.42 PWCF described how building a relationship with the interventionist helped them to consider ways of increasing their level of adherence to medication. PWCF in this sample found having their data visible to themselves and others motivating, particularly if they received praise from others about the progress they had made. The intervention was tailored to individuals but there were challenges in how the intervention fitted into some patients’ busy lives when delivered through a desktop computer. Interventionists identified that patients with moderate adherence rates were more likely to benefit from the intervention. PWCF in the control arm had not seen their adherence data or other parts of the intervention, indicating that the level of contamination was low.
The feasibility study led to 25 key changes to RCT procedures and the intervention.43 Plans to develop an app for mobile phones were progressed. Changes were made to CFHealthHub to make it easier for interventionists to view and edit prescription data and to handle alternating treatment regimens. Other changes to CFHealthHub included making graphs more easily interpretable and adding descriptions to videos so that they could be found more easily by PWCF. Changes to the interventionist manual increased the emphasis on ‘active ingredients’, introduced intervention triggers for reduced adherence or exacerbations and introduced new habit formation sessions. The need for increased numbers of protocolised intervention review sessions arose because a focus on RCT recruitment targets gave interventionists inadequate time to deliver review visits, which were critical for updating personalised action plans and updating coping plans. For the same reason, we planned for the subsequent full-scale RCT to have a longer accrual window. Training and job specifications were modified to suit interventionists from different disciplines and manage expectations about the need for travel and flexible working.
Conclusions
We concluded that, with improved intervention/research processes and lower monthly participant recruitment targets, a full-scale RCT and the intervention were feasible.