The Co-Development and Feasibility of an Interstitial Lung Disease (ILD) Fatigue and Breathlessness (‘FAB’) Programme using the Medical Research Council (MRC) Framework for Complex Interventions: A Theory-Based, Mixed-Method Study

Background Interstitial Lung Diseases (ILD) are characterised by inflammation and scarring (fibrosis) of lung tissue. Fibrosis is irreversible and frequently progressive. Symptoms include debilitating breathlessness, cough and fatigue. Management focuses on slowing disease progression with medication, relieving symptoms and optimising quality-of-life (QoL). Supported self-management improves people's ability to manage their health through education, peer support and coaching, potentially improving wellbeing and clinical outcomes and reducing health costs. Preliminary work suggests the Fatigue and Breathlessness (FAB) self-management programme is acceptable and effective. Further development and evaluation of this complex intervention will establish its theoretical basis. Stakeholder involvement will ensure it is deliverable in various settings and effective for participants and carers, particularly frail, geographically/socially isolated and those who speak English as a second language. Research question What programme theory underpins the Fatigue and Breathlessness supported self-management intervention and how can this be used to co-produce a patient-centred, ILD-specific programme, which is acceptable and deliverable in diverse real-world settings? Aims Establish a theoretical basis for an ILD-specific FAB programme Refine this programme through co-design with key stakeholders Pilot the refined programme to test acceptability for patients, carers and healthcare providers Identify and begin to quantify costs/benefits to inform future economic evaluation Methods and Timelines The project is based on the MRC Framework for Complex Interventions and consists of three interrelated phases: Phase 1 (Months 4-12) Realist synthesis will develop the programme theory underpinning the intervention, informed by the patient advisory group (PAG). Phase 2 (Months 13-18) Co-design involving key stakeholders (including people with ILD, carers, healthcare professionals and representatives from global majority communities) will refine the FAB programme and develop associated multi-lingual resources. Phase 3 (Months 22-33) A multi-site feasibility study will be completed. Participants (n=12-18) will undertake the programme either face-to-face or self-directed, with one follow up phone-call. Data from one programme cycle for both modes of delivery will include demographics, pulmonary function tests and patient-reported measures (PRMs) at baseline, 1 and 3. Carers (n=4) will also complete PRMs. Economic evaluation data (EQ-5D-5L, ICECAP-O/A and Healthcare Utilisation) will be collected at baseline, 1 and 3 months. Data collected will characterise the population, compare PRM scores pre and post-intervention and inform full-scale evaluation study design. Qualitative evaluation to capture perceptions, experience and limitations. Online interviews will be undertaken with participants (1 month), carers (1month) and non-completer participants (4 weeks after last contact). A facilitator focus group will be completed (1 month). Transcripts will undergo reflexive thematic analysis. Anticipated impact and dissemination This will be the first formal feasibility test of the FAB programme and first attempt to develop an ILD-specific programme addressing the needs of underserved populations. Outputs include a new programme theory, an ILD-specific supported self-management programme deliverable in healthcare settings or homes, multi-lingual person-centred resources, training manuals and data to support use of the programme in other disease areas/settings. Results will be disseminated nationally and internationally via social media networks/websites, patient support groups, charities, press releases, presentations with patient-partners at professional meetings, conference abstracts and journal articles.