Digital Therapeutics Research, Case Studies and Evaluations.
Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial
Early Study (MMH-R03) published in ersjournals.com on 26 October 2020
- Hull York Medical School, Hull, UK
- Imperial College London, London, UK
- Hampshire Hospitals NHS Foundation Trust – Basingstoke Hospital, Basingstoke, UK
- West Hertfordshire Hospital NHS Trust – Hemel Hempstead Hospital, Hemel Hempstead, UK
- mymhealth Limited, Bournemouth, UK
- University of Southampton Faculty of Medicine, Southampton, UK
First publication of complete results for a preliminary trial of a self-management intervention using a scalable app ( myCOPD) demonstrated signals of potential clinical benefit in a population of patients with mild-moderate and newly diagnosed COPD over a 90 day period.
The results from the EARLY trial (MMH-R03), funded by an UKRI Innovate UK Grant to my mhealth were published in ersjournals.com.
Self-management interventions in COPD aim to improve patients’ knowledge, skills and confidence to make correct decisions, leading to an improvement in health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.
We explored its impact in patients with mild-moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised-controlled trial of myCOPD compared with usual care. The co-primary outcomes were between group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.
60 patients were randomized overall (29 myCOPD, 31 usual care). Groups were balanced for FEV1% predicted, but baseline imbalance between groups for exacerbation frequency and CAT score. There was a trend to lower CAT scores in the myCOPD arm, but due to the size of the study there was no significant adjusted mean difference in CAT score at study completion, -1.27 (95% CI -4.47 to 1.92, p=0.44) lower in myCOPD. However, increasing app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was much lower in the myCOPD arm (adjusted odds ratio of 0.30 (0.09; 1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (0.46; 5.85) in favour of myCOPD.
The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique, this confirms the finding from previous studies that myCOPD can reduce inhaler technique errors by >70%. The findings of this study will now be used to power a much larger RCT to investigate the impact of myCOPD in this patient population.
Read the full paper on ersjournals.com
