Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind implementation trial
Lead Research Organisation:
University of Edinburgh
Department Name: College of Medicine & Vet Medicine
Abstract
Many people with chronic respiratory diseases (CRDs) such as chronic obstructive pulmonary disease, asthma, post-TB damage have disabling symptoms, especially breathlessness, which affect their day-to-day activities. Breathlessness is uncomfortable and frightening, so people tend to avoid activities that make breathlessness worse. Then, because they are not doing any exercise, muscles weaken and they become 'unfit', which makes activities even harder. This affects quality of life, and depression is common.
HOW CAN PULMONARY REHABILITATION (PR) HELP?
PR provides a supervised programme of exercise to reverse this vicious circle. PR combines endurance and muscle strengthening exercises, with education about the causes and treatment of CRDs, and coping with breathlessness. At the end of a course of PR, people with CRDs are less breathless and can do more, improving their quality of life.
WHY DO WE NEED THIS TRIAL?
Almost all PR trials were done in high-income countries, with well-equipped gyms and usually for people with one disease. In low- and middle-income countries (LMICs), PR Centres often have less equipment and limited access to tests that allow accurate diagnosis of different types of CRD. Another problem is distance; travelling to a Centre 16 times in 8 weeks may be difficult in rural LMICs, so home-based PR may be useful.
Our questions are:
* Does PR delivered in a low resource setting improve exercise capacity and quality of life in people with CRD?
* Is PR delivered at home as effective as centre-based PR?
* Do benefits of PR last 6 months?
* How much does PR cost?
* What do patients, PR therapists and professionals think of the services?
PULMONARY REHABILITATION (PuRe) TRIAL
We will recruit 465 adults with CRD from four centres (Bangladesh, India x2, Malaysia) and allocate them by chance to one of three groups:
* Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre
* Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone
* Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR
OUTCOMES AND EXPECTED BENEFITS
At the end of the PR programme we will assess exercise capacity, quality of life, breathlessness, anxiety and depression, and again 6-months later to measure whether benefits are maintained. We will measure use of healthcare resources to assess the cost implications for the health service.
IF SUCCESSFUL, HOW CAN THIS BE ROLLED OUT IN LMICS?
We will interview participants to find out what they think of the PR. We will ask the therapists about the practicalities of delivering PR in their Centre and at home and how they overcame any problems. We will interview referring clinicians, health service managers and policymakers to understand how a service might be implemented and sustained in the four different settings.
STAKEHOLDER AND COMMUNITY ENGAGEMENT
Two people with CRD are members of the project team (Ms Banu, Bangladesh; Mr Ku, Malaysia), and we will collaborate with community groups in each of the centres throughout the trial. Proactive stakeholder engagement will ensure our findings influence professionals and policymakers.
WHO IS DOING THIS RESEARCH?
Our team includes people with CRD, clinicians, therapists, researchers, statisticians, health economists and health psychologists from the University of Edinburgh and the four Centres. Together we have extensive experience in respiratory care, PR and conducting trials. Sharing that expertise with colleagues will help build research capacity in all the Centres.
SHARING OUR FINDINGS
We are part of the NIHR Global Health Research Unit RESPIRE and will use their social media and networks to tell people about the PuRe trial and work with policymakers to promote change. We will present at conferences and write papers for scientific journals.
HOW CAN PULMONARY REHABILITATION (PR) HELP?
PR provides a supervised programme of exercise to reverse this vicious circle. PR combines endurance and muscle strengthening exercises, with education about the causes and treatment of CRDs, and coping with breathlessness. At the end of a course of PR, people with CRDs are less breathless and can do more, improving their quality of life.
WHY DO WE NEED THIS TRIAL?
Almost all PR trials were done in high-income countries, with well-equipped gyms and usually for people with one disease. In low- and middle-income countries (LMICs), PR Centres often have less equipment and limited access to tests that allow accurate diagnosis of different types of CRD. Another problem is distance; travelling to a Centre 16 times in 8 weeks may be difficult in rural LMICs, so home-based PR may be useful.
Our questions are:
* Does PR delivered in a low resource setting improve exercise capacity and quality of life in people with CRD?
* Is PR delivered at home as effective as centre-based PR?
* Do benefits of PR last 6 months?
* How much does PR cost?
* What do patients, PR therapists and professionals think of the services?
PULMONARY REHABILITATION (PuRe) TRIAL
We will recruit 465 adults with CRD from four centres (Bangladesh, India x2, Malaysia) and allocate them by chance to one of three groups:
* Centre-PR: a programme of exercise and education twice a week for 8 weeks at a PR Centre
* Home-PR: a programme of exercise and education twice a week for 8 weeks in their own homes, supervised remotely by video-call/telephone
* Usual Care: usual clinical care. At the end of the trial, this group will be offered their choice of Centre-PR or Home-PR
OUTCOMES AND EXPECTED BENEFITS
At the end of the PR programme we will assess exercise capacity, quality of life, breathlessness, anxiety and depression, and again 6-months later to measure whether benefits are maintained. We will measure use of healthcare resources to assess the cost implications for the health service.
IF SUCCESSFUL, HOW CAN THIS BE ROLLED OUT IN LMICS?
We will interview participants to find out what they think of the PR. We will ask the therapists about the practicalities of delivering PR in their Centre and at home and how they overcame any problems. We will interview referring clinicians, health service managers and policymakers to understand how a service might be implemented and sustained in the four different settings.
STAKEHOLDER AND COMMUNITY ENGAGEMENT
Two people with CRD are members of the project team (Ms Banu, Bangladesh; Mr Ku, Malaysia), and we will collaborate with community groups in each of the centres throughout the trial. Proactive stakeholder engagement will ensure our findings influence professionals and policymakers.
WHO IS DOING THIS RESEARCH?
Our team includes people with CRD, clinicians, therapists, researchers, statisticians, health economists and health psychologists from the University of Edinburgh and the four Centres. Together we have extensive experience in respiratory care, PR and conducting trials. Sharing that expertise with colleagues will help build research capacity in all the Centres.
SHARING OUR FINDINGS
We are part of the NIHR Global Health Research Unit RESPIRE and will use their social media and networks to tell people about the PuRe trial and work with policymakers to promote change. We will present at conferences and write papers for scientific journals.
Technical Summary
PR is a comprehensive, multidisciplinary, individually-tailored intervention that overcomes the deconditioning induced by chronic respiratory diseases (CRDs). In LMICs, CRDs may be poorly differentiated, and PR inaccessible/under-resourced
AIM: To test the clinical/cost effectiveness, sustainability at 6-months, acceptability and implementability of Centre- or Home-PR delivered in low-resource centres for people with CRDs compared to usual care
SETTING: Four Centres (Bangladesh, India x2, Malaysia)
PARTICIPANTS: 465 adults with symptomatic CRD
DESIGN: 3-arm individually-randomised, assessor-blinded 6-month hybrid-1 implementation trial, with health economic and process evaluations
INTERVENTIONS: Following initial centre-based teaching of personalised exercise/education programme, two approaches to delivering PR:
1) Centre-PR: centre-based classes twice weekly for 8 weeks
2) Home-PR: Remotely supervised sessions at home twice weekly for 8 weeks
Usual care group: Locally available healthcare (choice of Centre- or Home-PR at the end of the trial)
PRIMARY OUTCOME: Endurance Shuttle Walking Test (ESWT)
Key secondary outcome: Quality of Life: St Georges Respiratory Questionnaire (SGRQ)
Other outcomes: mMRC Dyspnoea Score; Hospital Anxiety and Depression Score; smoking status; Activities of Daily Living; Physical Activity; adverse events; use of healthcare resources
DATA COLLECTION: Researcher-blind assessments (baseline; post-PR; 6-months)
ANALYSIS: ESWT will be analysed using a normal linear model, with treatment allocation, baseline ESWT and Centre included as fixed effect covariates
HEALTH ECONOMIC EVALUATION: Cost-consequence analysis to enable potential decision makers to select outcomes most pertinent to their circumstances
PROCESS EVALUATION: Mixed methods assessment of fidelity/adaptation, mechanisms of action, acceptability and sustainability
DISSEMINATION: High impact publication; conference presentations; professional networks; social media
AIM: To test the clinical/cost effectiveness, sustainability at 6-months, acceptability and implementability of Centre- or Home-PR delivered in low-resource centres for people with CRDs compared to usual care
SETTING: Four Centres (Bangladesh, India x2, Malaysia)
PARTICIPANTS: 465 adults with symptomatic CRD
DESIGN: 3-arm individually-randomised, assessor-blinded 6-month hybrid-1 implementation trial, with health economic and process evaluations
INTERVENTIONS: Following initial centre-based teaching of personalised exercise/education programme, two approaches to delivering PR:
1) Centre-PR: centre-based classes twice weekly for 8 weeks
2) Home-PR: Remotely supervised sessions at home twice weekly for 8 weeks
Usual care group: Locally available healthcare (choice of Centre- or Home-PR at the end of the trial)
PRIMARY OUTCOME: Endurance Shuttle Walking Test (ESWT)
Key secondary outcome: Quality of Life: St Georges Respiratory Questionnaire (SGRQ)
Other outcomes: mMRC Dyspnoea Score; Hospital Anxiety and Depression Score; smoking status; Activities of Daily Living; Physical Activity; adverse events; use of healthcare resources
DATA COLLECTION: Researcher-blind assessments (baseline; post-PR; 6-months)
ANALYSIS: ESWT will be analysed using a normal linear model, with treatment allocation, baseline ESWT and Centre included as fixed effect covariates
HEALTH ECONOMIC EVALUATION: Cost-consequence analysis to enable potential decision makers to select outcomes most pertinent to their circumstances
PROCESS EVALUATION: Mixed methods assessment of fidelity/adaptation, mechanisms of action, acceptability and sustainability
DISSEMINATION: High impact publication; conference presentations; professional networks; social media
