Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: The 3-arm multi-country randomised implementation PuRe trial

The PuRe trial is a 3-arm individually randomised implementation trial evaluating clinical effectiveness of pulmonary rehabilitation (PR) for people with chronic respiratory disease (CRD) in Low- and Middle-Income Countries (LMICs), with a health economic evaluation and mixed-methods process evaluation. Background: PR is a comprehensive, multidisciplinary, individually tailored intervention that overcomes the deconditioning induced by CRDs, but most of the evidence is disease-specific and generated in high-income settings. In LMICs, substantial differences in resources, awareness, culture, healthcare configuration and disease profile mean that CRDs may be poorly differentiated and PR inaccessible. PuRe aims to provide evidence to inform feasibility, effectiveness and sustainability of PR in low resource community settings. Methods: We will recruit 465 people with symptomatic CRD from four centres in SE Asia. After treatment optimisation and baseline assessments conducted at Centres, participants will be randomised to: 1. Centre-PR: Centre-based sessions twice weekly for 8 weeks 2. Home-PR: Remotely supervised sessions at home twice weekly for 8 weeks 3. Usual care: Locally available healthcare, offered choice of Centre- or Home-PR at end of the trial Outcomes will be assessed at baseline, 12-weeks and 6-months by researchers blinded to allocation • Endurance Shuttle Walk Test (primary), • St. Georges Respiratory Questionnaire, (secondary) • Breathlessness, anxiety/depression, activities of daily living, physical activity Analysis: • Effectiveness: ESWT/SGRQ will be analysed using a normal linear model, with treatment allocation, baseline ESWT/SGRQ and Centre included as fixed effect covariates • Health economic evaluation will assess healthcare costs, out of pocket expenses and impact on work productivity • Mixed methods process evaluation will assess fidelity/adaptation, mechanisms of action, acceptability, sustainability Questions: 1. How should we ensure fidelity to the intervention, with adaptation at the centres to tailor PR to their context? 2. Who will be the key stakeholders that we should involve to ensure sustainable implementation?