A randomised controlled feasibility trial of E-health application supported care vs usual care after exacerbation of COPD: the RESCUE trial

Abstract

Exacerbations of COPD are one of the commonest causes of admission and readmission to hospital. The role of digital interventions to support self-management in improving outcomes is uncertain. We conducted an open, randomised controlled trial of a digital health platform application (app) in 41 COPD patients recruited following hospital admission with an acute exacerbation. Subjects were randomised to either receive usual care, including a written self-management plan (n = 21), or the myCOPD app (n = 20) for 90 days. The primary efficacy outcome was recovery rate of symptoms measured by COPD assessment test (CAT) score. Exacerbations, readmission, inhaler technique quality of life and patient activation (PAM) scores were also captured by a blinded team. The app was acceptable in this care setting and was used by 17 of the 20 patients with sustained use over the study period. The treatment effect on the CAT score was 4.49 (95% CI: -8.41, -0.58) points lower in the myCOPD arm. Patients' inhaler technique improved in the digital intervention arm (101 improving to 20 critical errors) compared to usual care (100 to 72 critical errors). Exacerbations tended to be less frequent in the digital arm compared to usual care; 34 vs 18 events. Hospital readmissions risk was numerically lower in the digital intervention arm: OR for readmission 0.383 (95% CI: 0.074, 1.987; n = 35). In this feasibility study of the digital self-management platform myCOPD, the app has proven acceptable to patients to use and use has improved exacerbation recovery rates, with strong signals of lower re-exacerbation and readmission rates over 90 days. myCOPD reduced the number of critical errors in inhaler technique compared to usual care with written self-management. This provides a strong basis for further exploration of the use of app interventions in the context of recently hospitalised patients with COPD and informs the potential design of a large multi-centre trial.

Keywords: Disease prevention; Respiratory tract diseases.

Conflict of interest statement

Competing interestsT.W. is the co-founder, shareholder and director, S.B. is the co-founder, shareholder and director M.N. and A.B are employees of Mymhealth Limited. T.W., S.B. and M.N. have received personal fees during the conduct of the study. B.G. and T.B. received grants from Mymhealth Limited. Outside the submitted work, T.B. has received grants from GSK and personal fees from AstraZeneca, GSK, Teva, Napp Pharmaceuticals and Novartis as well as non-financial support from GSK, Teva and Novartis. Outside the submitted work, T.W. has received grants from GSK, AstraZeneca and Synairgen and has received personal fees from AstraZeneca, Synairgen and BI. A.J.C., J.W., T.J., D.N., A.W., D.C., M.J., J.E. and V.C. have nothing to disclose.

© The Author(s) 2020.

Figures

Fig. 1. Flow diagram of study participants.

Indicated is the consort flowchart of study participants through the study. Showing the number of eligible patients, number excluded and reasons for exclusion, number randomised to each arm, number of loses to follow up in each arm and number included in the analysis for each arm.

Fig. 2. Mean weekly usage and mean number of users by week of the trial.

Indicated is the mean weekly usage (green) and number of users of the app (red) over the 12 week study period. Mean weekly usage is the number of days per week that the app was accessed. The number of users is the number of participants that used the app at least once in that week.

Fig. 3. Standardised CAT score by trial arm over time.

Indicated is the mean standardised CAT scores over the 3-month study in both the Treatment as Usual (Red) and MyCOPD App (Blue) arms. 95% confidence intervals are shown in light grey.

Fig. 4. Rate ratio estimates of numbers of exacerbations and inhaler errors.

Indicated are the incidence rate ratio estimates (and 95% confidence intervals) for number of exacerbations and inhaler errors.