A randomised controlled feasibility trial of a pulmonary rehabilitation programme adapted to the Georgian context compared to usual care, for patients with symptomatic COPD of MRC grade 2+.
RESEARCH QUESTION
What is the feasibility of an RCT to determine the effectiveness of a PR programme adapted to the Georgian context compared to usual care for patients with symptomatic COPD of MRC grade 2+?
Two phases:
- Qualitative study, consisting of focus groups with healthcare professionals and COPD, patients to inform the tailoring of a PR programme to the Georgian context
- Randomised controlled feasibility trial of the new PR programme
SUMMARY
COPD burden and health system in Georgia
Chronic Obstructive Pulmonary Disease (COPD) is a long-term incapacitating respiratory condition, responsible for substantial ill health (4th leading cause of death worldwide) [WHO 2017; GOLD 2017]. The burden of Chronic Respiratory diseases (CRD) is growing in Georgia and age standardized mortality indicator during last 20 years shifted from 7th place to 3rd (from year 1990 to 2013). The main risk factors for chronic respiratory diseases (CRDs) in Georgia are smoking, indoor air pollution and outdoor air pollution. 33% of Georgian population are smokers. There is no comprehensive and integrated tobacco dependence and cessation program and availability of pharmacotherapy is limited in practice.
BRIEF METHODOLOGY
The study will have two phases:
1) Tailoring of content of pulmonary rehabilitation to fit the Georgian health service and setting. The adaptation process will consider: a) components, including whether training on inhaler technique, medication adherence, rescue medications is appropriate, and whether to include smoking cessation as part of PR or refer to a specialist smoking cessation programme and b) delivery including who would be first point of contact, setting of delivery (group or home based), acceptable and affordable intensity and duration of programme, type, duration and intensity of exercise training that would be acceptable and feasible. This phase will consider which are the essential elements of a PR programme for delivery to all participants, and which elements that would be tailored to need.
Stakeholder interviews will inform the adaptation. These will include primary and secondary care clinicians, therapists and patients with COPD. Where possible, focus group discussions will be used
The discussions will use the APEASE criteria - affordability, practicability, effectiveness (and cost-effectiveness), acceptability, side-effects (and safety), and equity [West 2015].
2) Randomised controlled feasibility trial
Population – people with symptomatic COPD identified from primary & secondary care. MRC 2+, with spirometry at entry to confirm COPD. Patients will be invited by their respiratory physician or via primary care.
Intervention – adapted pulmonary rehabilitation, tailored to patient need (based on MRC score and ISWT results)
Control group - waiting list control to be offered 2-3 hour educational and exercise session after 6 months, with follow-up at the end of programme for this group.
Outcomes – at programme end and 6m
Feasibility outcomes: delivery with fidelity, acceptability to participants, recruitment rate, follow-up rate at 6 months, adherence to intervention, ability to carry out trial procedures, feasibility of methods to measure the costs of the PR.
Outcome measures to inform a future trial to evaluate clinical and cost effectiveness: HRQoL (Chronic Respiratory Questionnaire (CRQ) or St George’s Respiratory Questionnaire (SGRQ)); exercise capacity measured by the ISWT; smoking status validated by cotinine/CO; COPD Assessment Test (CAT); self-reported physical activity (TBC); self-efficacy; anxiety and depression measured by the Georgian Hospital Anxiety and Depression Scale; self-reported exacerbations; health care utilisation including hospital admissions; costs/resource use; cost-effectiveness.
Sample size – n=30 per arm (60 total) [Lancaster 2004]
Process measures – Fidelity of delivery of the programme by the rehabilitation specialists will be determined by observation using a structured checklist; attendance at sessions, or adherence to exercise prescription (if PR sessions are home-based). The reach of the adapted PR programme will also be considered; examining the characteristics of the participants, and determining whether we were able to recruit the more socio-economically disadvantaged members of the population and achieve geographical reach.
Qualitative interviews will be carried out with the staff who delivered the PR programme about training, confidence with delivery and how PR fits with the rest of health care for people with COPD.