Mobile health pulmonary rehabilitation (m-PR): a randomised controlled equivalence trial.

Abstract

Mobile health (mHealth) is a novel model of care that may overcome barriers to pulmonary rehabilitation (PR) access. This study determined if mHealth PR was equivalent to centre-based PR (CB-PR) in improving exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD). Single-blinded, multicentre, randomised controlled equivalence trial using an intention-to-treat analysis. Participants completed 8 weeks of either mHealth PR, using the mobile PR (m-PR) application and supported by telephone calls, or CB-PR. Co-primary outcomes, measured at baseline and end-intervention, were change in 6 minute walk distance (6MWD) and COPD assessment test (CAT) score, with an equivalence margin of 30 m and 2 points, respectively. 90 participants were randomised (mean (SD), m-PR n = 44: age 75 (7) years; forced expiratory volume in one second (FEV₁) 58 (15) % predicted; CB-PR n = 46: age 75 (6) years; FEV₁ 55 (14) % predicted) with 38 m-PR participants and 42 CB-PR participants completing at least one primary outcome. At end-intervention, there was no between-group difference in 6MWD (mean difference (MD) 13 m, 95% CI -6 to 31), indicating equivalence of m-PR to CB-PR. There was a significant between-group difference in CAT score (MD -4.9 points, 95% CI -7.2 to -2.6), with both limits of the CI exceeding the equivalence margin, indicating superiority of m-PR. An mHealth PR programme resulted in equivalent improvements in exercise capacity and superior improvements in health status when compared with CB-PR in people with COPD. mHealth PR could be effective as a management option for people with COPD with adequate digital literacy. ACTRN12619001253190.