Protocol for a single-centre mixed-method pre–post single-arm feasibility trial of a culturally appropriate 6-week pulmonary rehabilitation programme among adults with functionally limiting chronic respiratory diseases in Malawi

Abstract

IntroductionMalawi has a substantial burden of chronic respiratory diseases (CRDs) which cause significant morbidity and loss of economic productivity, affecting patients, families and health systems. Pulmonary rehabilitation (PR) is a highly recommended non-pharmacological intervention in the clinical management of people with CRDs. However, Malawi lacks published evidence on the implementation of PR for people with CRDs. This trial will test the feasibility and acceptability of implementing a culturally appropriate hospital-based PR programme among adults with functionally limiting CRDs at Queen Elizabeth Central Hospital in Blantyre, Malawi.Methods and analysisThis is a single-centre mixed-methods pre–post single-arm feasibility trial. Ten patients aged ≥18 years, with a spirometry confirmed diagnosis of a CRD and breathlessness of ≥2 on the modified Medical Research Council dyspnoea scale, will be consecutively recruited. Their baseline lung function, exercise tolerance and health status will be assessed; including spirometry, Incremental Shuttle Walk Test and Chronic Obstructive Pulmonary Disease Assessment Test, respectively. Pretrial semistructured in-depth interviews will explore their experiences of living with CRD and potential enablers and barriers to their PR uptake. Along with international PR guidelines, these data will inform culturally appropriate delivery of PR. We initially propose a 6-week, twice-weekly, supervised centre-based PR programme, with an additional weekly home-based non-supervised session. Using combination of researcher observation, interaction with the participants, field notes and informal interviews with the participants, we will assess the feasibility of running the programme in the following areas: participants’ recruitment, retention, engagement and protocol adherence. Following programme completion (after 6 weeks), repeat assessments of lung function, exercise tolerance and health status will be conducted. Quantitative changes in clinical outcomes will be described in relation to published minimal clinically important differences. Post-trial semistructured interviews will capture participants’ perceived impact of the PR programme on their quality of life, enablers, and barriers to fully engaging with the programme, and allow iteration of its design.Ethics and disseminationEthical approval for this trial was obtained from University of Malawi College of Medicine Research and Ethics Committee (COMREC), Blantyre, Malawi (protocol number: P.07/19/2752) and University of Leicester Research Ethics Committee, Leicester, UK (ethics reference: 31574). The results of the trial will be disseminated through oral presentations at local and international scientific conferences or seminars and publication in a peer-reviewed journal. We will also engage the participants who complete the PR trial and the Science Communication Department at Malawi-Liverpool-Wellcome Trust Clinical Research Programme to organise community outreach activities within Blantyre to educate communities about CRDs and PR. We will also broadcast our trial results through national radio station programmes such as the weekly “Thanzi la Onse” (Health of All) programme by Times Radio Malawi. We will formally present our trial results to Blantyre District Health Office and Malawi Ministry of Health.Trial registration numberISRCTN13836793.

A Qualitative Exploration of Patients’ Experiences of Living with Chronic Respiratory Diseases before and after Participating in a Pulmonary Rehabilitation Program at a Tertiary Hospital in Malawi, and Their Suggestions to Improve a Future Program

“…This qualitative study is part of the first feasibility and acceptability trial of PR in Malawi (32) and responds to other researchers’ calls for PR in Malawi (33, 34). But the theoretical transferability (35) of our findings is limited by the heterogeneity of study participants (for example, various CRDs, and comorbidities among participants including HIV infection) as well as the study having been conducted at a single site with a relatively small sample of patients.…”

“…Our published protocol, available elsewhere (13), includes detailed information about study design, participants’ sample size, recruitment process, eligibility criteria, and data collection. A summary is presented here.…”

“…For an overview of quantitative measures included pre- and post-PR, we refer the reader to our published protocol (13).…”

“…A total of fourteen protocol-eligible (13) patients (eight females and six males, aged ≥18 years) presenting with functionally limiting CRD symptoms to the Chest Clinic at QECH were consecutively identified, invited, and consented (by TM, BC, MMi, MMa, and BC) to participate in a PR program at the QECH's Physiotherapy Department. However, four did not participate: one male patient died of a cardiovascular complication, one female patient relocated to another city, and two patients (one male and one female) became unreachable.…”