This section outlines the process of planning, designing and creating, refining and documenting the intervention35 that the team undertook with input from the PPI panel and alongside the technical development of the digital platform (see Work package 1: developing the technology and infrastructure to collect adherence data).
Intervention development combined a ‘theory- and evidence-based’ approach36 [the behaviour change wheel (BCW) approach]37 with a ‘target population-based’ approach [the person-based approach (PBA)].38 The BCW considers capability, opportunity and motivation in relation to behaviour (i.e. nebuliser adherence) and, through a series of stages, systematically selects intervention functions and behaviour change techniques. The PBA utilises mixed methods with people from the target population (i.e. adults with CF) to inform all of the intervention development stages in an iterative process.
Stage 1: planning the intervention
We undertook a needs analysis informed by the qualitative research undertaken in WP 2, a literature review and PPI panel input and determined which capability, opportunity and motivation barriers the intervention should address. The qualitative research helped us to understand the context of PWCF’s lives.
Stage 2: designing and creating the intervention
We used the BCW approach to identify what ways to enact the intervention, and identified suitable behaviour change techniques, drawing on relevant theory and evidence. We embedded these in a prototype CFHealthHub website. We considered how the intervention could be tailored to meet the needs of patients with different needs. We considered the competencies required by interventionists and developed job descriptions and a prototype training manual.
Stage 3: refining the intervention
Refinement of the prototype intervention took place iteratively based on feedback from users. We undertook two studies with participants who were PWCF aged ≥ 16 years and on the CF registry. Participants were provided with an eTrack (PARI GmbH, Starnberg, Germany) nebuliser and Qualcomm (San Diego, CA, USA) hub and were given access to the CFHealthHub digital platform. Five participants took part in the first study, which assessed the ability of the system to successfully record and display nebulisations. Participants were interviewed 1 month later about their experiences and views. We made changes to the intervention based on this feedback. A total of 22 participants took part in the second study. During the intervention development phase our research physiotherapist delivered the intervention of four sessions to each participant. We conducted 18 semistructured telephone interviews with participants in different cycles of the software development to ask about acceptability, appearance and functionality of the digital platform and suggestions for improvements. We identified during this work the need for ‘talking heads’ videos of other PWCF to help participants learn how to improve their adherence (see Work package 2.1C: patient story video interviews for use in the CFHealthHub intervention). We also conducted six in-depth think-aloud interviews with participants while they were using the platform and these were screen- and audio-captured. We interviewed the physiotherapist delivering the intervention about their views. All of this feedback was used to improve the prototype digital platform and training manual.
Stage 4: documenting the intervention
At the end of this process we created an intervention manual that outlined the components of the intervention, the features and functions of the CFHealthHub digital platform and the proposed structure of delivery by health-care professionals/interventionists. An associated training programme for interventionists was also developed.
The CFHealthHub intervention
The CFHealthHub intervention is described in detail in Appendix 2 using template for intervention description and replication (TIDieR) guidelines.39 The intervention comprises a web platform and app, which display graphs and tables of objectively measured nebuliser adherence and include modules of behaviour change techniques designed to increase motivation for adherence, to address capability and opportunity barriers and to build habits for treatment taking, and an intervention manual including procedures and worksheets for delivery by a health-care professional (interventionist).
The content of the website/app is tailored to individual participants’ needs based on their nebuliser medication prescription and their responses to the Beliefs about Medicines Questionnaire40 and displays individual real-time adherence data and personalised information in a ‘Toolkit’ area.
Participants are supported to interact with the digital platform content and tools in sessions by trained interventionists following a manualised delivery procedure, with a person-centred communication style. Six sessions (one ‘first intervention’ visit, 40–60 minutes; two ‘intermediate’ reviews, 5–15 minutes each; two ‘main’ reviews, 30–45 minutes each; one ‘phase’ review, 20–30 minutes) were usually delivered over a 12-week phase of delivery, with phase reviews every 12 weeks thereafter, or every 6 weeks thereafter for participants with objectively measured adherence of < 25%. Participants with a high level of adherence during the baseline period of the study (> 80%) received two sessions (one first intervention visit and one phase review), with phase reviews every 12 weeks thereafter. Additional blocks of sessions (a ‘phase’) were offered when (1) participants requested further support, (2) participant’s adherence was reduced by 20% in a 4-week period or (3) participants received intravenous (i.v.) therapy for an exacerbation. First intervention sessions were always delivered face to face, whereas review sessions were delivered either face-to-face or by telephone, allowing the interventionist to intervene with one set of sessions or repeat further sets of sessions under certain circumstances. This means that, if used in the real world, the interventionist-delivered component of the intervention may be used throughout a person’s lifetime if their adherence drops for any reason.
A full description of the intervention is available in Appendix 2.
