DEPARTMENT FOR SCIENCE, INNOVATION AND TECHNOLOGY

Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind implementation trial

Project disclaimer

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Description

MRC AGHRB Award to conduct a 3-arm individually randomised, assessor-blinded hybrid-1 implementation trial to evaluate clinical effectiveness of pulmonary rehabilitation (PR) for people with chronic respiratory disease (CRD), in Bangladesh and India

Objectives

OVER-ARCHING GOALS I. To conduct a 3-arm individually randomised, assessor-blinded hybrid-1 implementation trial evaluating clinical effectiveness of pulmonary rehabilitation (PR) for people with chronic respiratory disease (CRD), with a health economic evaluation and mixed-methods process evaluation. II. To work with stakeholders to promote implementation of PR in routine practice III. To strengthen research capacity within participating centres I. THE PuRe TRIAL We aim to investigate two approaches to delivering PR for people with CRD in four diverse low resource settings in South/Southeast Asia: * Centre-PR: in which patients attend PR classes twice weekly for 8 weeks at a PR Centre * Home-PR: in which patients are supported remotely twice weekly for 8 weeks to undertake the PR sessions at home. A Usual Care group will receive the routine care available within their local healthcare service. Research questions In people with CRD: 1. Compared to usual care, does Centre-PR or Home-PR improve exercise tolerance (primary outcome) and quality of life (key secondary outcome) when delivered in a low-resource settings? 2. Does supervised Home-PR achieve outcomes that are non-inferior to Centre-PR? 3. Is the impact of Centre-PR and/or Home PR sustained at 6-months? 4. Does Centre-PR or Home-PR lead to changes in healthcare utilisation, patient expense, and work productivity over 6-months, in each country and across countries, and what are their associated costs from healthcare provider, patient, and societal perspectives? 5. Are Centre-PR or Home-PR programmes acceptable, feasible and implementable? Outcomes of interest The trial will take place in four diverse sites in low- and middle-income countries (LMICs) in South/South-East Asia (Bangladesh, India (2 sites, Vellore and Pune) and Malaysia) recruiting approximately equal numbers of participants. The primary outcome (ESWT: endurance shuttle walking test), key secondary outcomes (HRQoL: health-related quality-of-life), and other secondary outcomes (anxiety/depression, breathlessness, manual muscle strength, physical activity) will be measured by blinded assessors within 2-weeks of completion of PR to assess effectiveness. We will reassess the outcomes at 6-months to assess sustainability. II. STAKEHOLDER ENGAGEMENT Engaging with stakeholders with both influence and interest is a key implementation strategy. We will use our Community Engagement and Involvement platform to establish networks ensuring we reach those with interest/power to effect change. III. CAPACITY BUILDING * Individuals: Each Centre has nominated a future research leader who has a budget of £3,000 to support training and travel to develop an aspect of their academic career. Monsur Habib (Bangaldesh) will focus on implementation and developing stakeholder engagement skills; Dhiraj Agarwal (India, Pune) will developing his trial management leadership skills; Biswajit Paul (India, Vellore) will focus on implementation research; Julia Enkasan (Malaysia) will focus on of healthcare systems research methodology). (See Letters of Support from the supervisor/mentors) * Affiliated PhD students: Two early career members of the PuRe team have been awarded RESPIRE PhDs: Diksha Singh (India, Pune) on the psychological component or PR, Soo Chin Chan (Malaysia) on overcoming implementation challenges throughout Malaysia. * PuRe teams: We have budgeted for a week's PuRe trial training in the Khulna Centre for key research and clinical members of the team. In addition, we have allocated a training budget of £2,000/Centre to enable training responsive to individual needs in the local teams. * Wider capacity building: We will optimise the opportunity of site visits by offering to lead training workshops (e.g. in trial design; trial management; process evaluations; clinical PR skills etc) for the wider teams in the centres.

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Location

The country, countries or regions that benefit from this Programme.

South Asia, regional

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