Feasibility of a pulmonary rehabilitation programme for patients with symptomatic chronic obstructive pulmonary disease in Georgia: a single-site, randomised controlled trial from the Breathe Well Group
Kate Jolly,
Jaime Correia-de-Sousa,
Sue Jowett,
Amanda Farley,
Peymane Adab,
Rachel E Jordan,
KK Cheng,
Sian Williams,
Chunhua Chi,
Rafael Stelmach,
Alice J Sitch,
Andrew P Dickens,
Kiran Rai,
Alexandra Enocson,
Alice M Turner,
Brendan Cooper,
Rachel Adams,
Nicola K Gale,
Mariam Maglakelidze,
Tamaz Maglakelidze,
Katarina Stavrikj,
Ia Kurua,
Nino Maglakelidze,
Ivane Chkhaidze,
Ketevan Gogvadze,
Natia Chkhaidze,
Helen Beadle,
Kelly Redden-Rowley,
Sonia Martins
Affiliations
Kate Jolly
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Jaime Correia-de-Sousa
Life and Health Sciences Research Institute, University of Minho, Braga, Portugal
Sue Jowett
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Amanda Farley
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Peymane Adab
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Rachel E Jordan
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
KK Cheng
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Sian Williams
International Primary Care Respiratory Group, Edinburgh, Scotland
Chunhua Chi
Department of General Practice, Peking University First Hospital, Beijing, 100034, China
Rafael Stelmach
Faculty of Medicine, University of São Paulo, São Paulo, Brazil
Alice J Sitch
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Andrew P Dickens
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Kiran Rai
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Alexandra Enocson
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Alice M Turner
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Brendan Cooper
Lung Function & Sleep, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
Rachel Adams
Institute of Applied Health Research, University of Birmingham College of Medical and Dental Sciences, Birmingham, UK
Nicola K Gale
Health Services Management Centre, University of Birmingham College of Arts and Law, Birmingham, UK
Mariam Maglakelidze
Georgian Respiratory Association, Tbilisi, Georgia
Tamaz Maglakelidze
Georgian Respiratory Association, Tbilisi, Georgia
Katarina Stavrikj
Centre for Family Medicine, Medical Faculty, Skopje, North Macedonia
Ia Kurua
Georgian Respiratory Association, Tbilisi, Georgia
Nino Maglakelidze
Georgian Respiratory Association, Tbilisi, Georgia
Ivane Chkhaidze
Georgian Respiratory Association, Tbilisi, Georgia
Ketevan Gogvadze
Georgian Respiratory Association, Tbilisi, Georgia
Natia Chkhaidze
M. Iashvili Children’s Central Hospital, Tbilisi, Georgia
Helen Beadle
Department of Physiotherapy, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
Kelly Redden-Rowley
iCares Directorate, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK
Sonia Martins
Family Medicine, ABC Medical School, São Paulo, Brazil
Objectives To assess the feasibility of delivering a culturally tailored pulmonary rehabilitation (PR) programme and conducting a definitive randomised controlled trial (RCT).Design A two-arm, randomised feasibility trial with a mixed-methods process evaluation.Setting Secondary care setting in Georgia, Europe.Participants People with symptomatic spirometry-confirmed chronic obstructive pulmonary disease recruited from primary and secondary care.Interventions Participants were randomised in a 1:1 ratio to a control group or intervention comprising 16 twice-weekly group PR sessions tailored to the Georgian setting.Primary and secondary outcome measures Feasibility of the intervention and RCT were assessed according to: study recruitment, consent and follow-up, intervention fidelity, adherence and acceptability, using questionnaires and measurements at baseline, programme end and 6 months, and through qualitative interviews.Results The study recruited 60 participants (as planned): 54 (90%) were male, 10 (17%) had a forced expiratory volume in 1 second of ≤50% predicted. The mean MRC Dyspnoea Score was 3.3 (SD 0.5), and mean St George’s Respiratory Questionnaire (SGRQ) 50.9 (SD 17.6). The rehabilitation specialists delivered the PR with fidelity. Thirteen (43.0%) participants attended at least 75% of the 16 planned sessions. Participants and rehabilitation specialists in the qualitative interviews reported that the programme was acceptable, but dropout rates were high in participants who lived outside Tbilisi and had to travel large distances. Outcome data were collected on 63.3% participants at 8 weeks and 88.0% participants at 6 months. Mean change in SGRQ total was −24.9 (95% CI −40.3 to –9.6) at programme end and −4.4 (95% CI −12.3 to 3.4) at 6 months follow-up for the intervention group and −0.5 (95% CI −8.1 to 7.0) and −8.1 (95% CI −16.5 to 0.3) for the usual care group at programme end and 6 months, respectively.Conclusions It was feasible to deliver the tailored PR intervention. Approaches to improve uptake and adherence warrant further research.Trial registration number ISRCTN16184185.
