A development study to examine feasibility and acceptability of pulmonary rehabilitation in Uganda for adults with chronic respiratory disease

Arising from respiratory infections such as TB and HIV, tobacco smoking and nutritional impairment, chronic lung disease (CLD) affects around one in five adults in Africa, and is a major threat to health. Patients with breathlessness related to CLD create large but silent burden of human suffering, damage to the economy through lost productivity and disability, and direct health service costs with frequent and prolonged hospital admissions. People with CLD are prone to breathlessness, inactivity, de-conditioning, declining health status and prognosis. CLDs are disproportionately prevalent in deprived populations and many sufferers can neither afford the drugs nor transport to medical clinics. While non-communicable diseases are now recognised as a major public health problem in Africa, CLDs are neglected as a health priority.

While medication may improve lung function and symptoms they do not change prognosis or rate of decline in lung function or health status. However these important systemic effects of CLDs are amenable to treatment with pulmonary rehabilitation (PR) which is a programme of exercise, and education and self management. There is strong evidence that PR improves health status, exercise capacity, social functioning and is recommended in international guidelines. PR involves existing local resources such as nurses, doctors, physiotherapists and clinic staff. PR allows patients to help each other and themselves, without major capital outlay or equipment. PR offers a major and radical new approach to CLDs, an important neglected group for whom no effective therapy is available. A literature review found no evidence of pulmonary rehabilitation being used in Sub Saharan Africa.

In a pilot PR study we set up and ran a programme in Mulago Hospital, Kampala. A multidisciplinary team of doctors, nurses, physiotherapist and others have run 2 groups with 23 patients with chronic lung damage secondary to pulmonary TB. Results confirm that the programme is feasible and acceptable to patients and to the hospital staff at all levels. Major improvements were seen in exercise capacity and health status. In many patients the experience was life changing, allowing severely incapacitated patients who were entirely dependent on others to now function normally in work and social activities. The patients in this pilot so far have been post tuberculosis patients, but we are now able to include patients with other CLDs.

The objective of this application is to develop PR to a point where it may be deployed widely in East Africa and assessed in a large trial. The main research questions are:

- What is the optimal design of the PR programme?
- What are the patient recruitment and retention strategies?
- What are the optimal assessment strategies and outcome measures?
- How can the training and roll-out be best achieved?

The study has quantitative and qualitative elements. We will continue the pilot PR programme at Mulago hospital for 3 more cohorts, totalling 30-40 people. Quantitative data will be recorded on recruitment, uptake and completion of PR. We will assess a range of measures including exercise capacity and quality of life, satisfaction, and evaluation of chest pains. In the qualitative study, detailed interviews will be held with 25 participants who have completed the programme and 5 interviews will be conducted with people who did not take part or complete PR, focusing on barriers to attending or completing PR. A focus group and up to 5 in depth interviews with stakeholders will explore practical issues of running and extending PR in Africa. Thematic analysis will be performed by Ugandan researchers in local languages initially with further framework analysis in collaboration with the UK team. To inform the development of a full grant application we will host a meeting of all stakeholders to disseminate the findings of this work and develop the strategy for rolling out PR in East Africa.

DESIGN- pre and post observational cohort study - a continuation of existing pilot Pulmonary rehabilitation (PR) programme with collection of quantitative data and detailed qualitative study on the optimisation of the programme contents, deployment and evaluation to inform the development of a large trial.

PARTICIPANTS: Three cohorts yielding 30-40 people who have completed the PR programme.

QUANTITATIVE: Details of those identified, invited, accepted and completed will be recorded. For all participants, we will record demographics, medical history and clinical features as before with new detailed evaluation of chest pains and haemoptysis. Outcome measures include incremental shuttle walking test, Clinical COPD questionnaire, MRC dyspnoea scale, spirometry and biometrics. Descriptive statistical analysis will assess the performance of the outcome measures

QUALITATIVE: Semi-structured interviews with 25 participants who have completed the programme will be conducted by experienced qualitative researchers. They will be recorded in native languages, fully transcribed and translated to English. The interviews will be flexibly guided by a list of topics including: (i) facilitators and barriers to attending the programme (ii) the impact of their respiratory disease on their lives before and after the programme (iii) problems caused by attending PR (iv) improvements in the PR or its assessment (v) maintenance after PR. Five semi-structured interviews will be conducted with people who did not take part or complete PR, focusing on barriers to attending or completing PR. A focus group and upto 5 in-depth interviews with stakeholders (clinicians, administrators, community representatives and the PR team) will explore practical issues of running and extending PR in Africa.
Thematic analysis will be performed by Ugandan researchers in local languages initially with further framework analysis of the translated transcripts in collaboration with the UK team.

The outcomes of this development trial and the potential large scale trial will help various beneficiaries. In addition to the benefits to the research team in developing large scale trials, the research team is part of a new centre in Kampala consisting of international researchers who have recently been successful in other academic research bids (around £300,000) and are creating the International Lung Investigation Unit. This development trial will help the centre build capacity as a centre of research excellence in Uganda to continue to develop and run important new studies related to CLDs. The wider beneficiaries and impacts are:

1. Patients with CLDs are common, COPD may affect 1 in 5 adults, and predominate in the lower socioeconomic groups who have few resources and are unable to pay for conventional medicines (which in any case are often not very effective). For the majority, there is no treatment and no hope. The patients stand to gain by improved symptoms, exercise capacity, mood and ability to be economically active. Their families will benefit if the patients make improvements and are no longer dependent on others for limited resources. This research will give a huge silent population of people with CLDs a voice and hope.

2. Patients with other chronic diseases such as heart failure may benefit from the lessons learned that rehabilitation without drugs can empower patients to dramatically improve their symptoms, disability and dependency.

3. Clinicians may benefit from having a new way to treat peoples' unremitting symptoms, they will gain from better awareness of CLDs and the importance of patients improving their health behaviours not just relying on drugs.

4. The health services in many countries struggle to manage the acute exacerbations of diseases like COPD which causes a large number of admissions. In the UK, COPD exacerbations are the second most common cause of emergency medical admissions, and the Director of Mulago Hospital states that prolonged and repeated admissions are a major burden to overstretched resources, creating a bed crisis that urgently needs addressing. The duration of admission and time to readmission may be improved by PR.

5. Society will benefit directly if PR allows more patients to be able to work and reduce dependence on others. By educating people about CLDs, their cause, and availability of treatment, and preventative measures such as reducing exposure to tobacco and cooking fire smoke may have profound public health benefits.

6. Policy makers in Uganda are already engaged in this work, through clinical contacts with the Ministry of Health and through our international links at WHO. We have an opportunity to influence commissioning of services to address an unmet need. This study represents a major silent and neglected health problem, using novel sustainable and scalable methods, which are applicable to a range of NCDs. The development trial will build on the work of the Fresh Air Uganda teams and as such this development trial has the support of the WHO's Global Alliance against Respiratory disease (GARD).

The research builds bridges across countries and continents, across disciplines and puts the patient at the centre of their own care which will enhancing cultural enrichment, quality of life, health and well-being and reduce social isolation and stigma.