Real-World Evidence and Randomised Controlled Trials

The research team at my mhealth have been working hard to ensure the support it provides to the NHS is evidence backed, and guaranteed to see results. The team has undertaken a number of clinical trials and real-world studies to ensure the platform is effective and able to support health services and patients.

Explore our peer-reviewed studies and real-world evidence to understand the effectiveness of my mhealth digital therapeutics.

Research MMH-R03

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 on 26 October 2020

  1. Hull York Medical School, Hull, UK
  2. Imperial College London, London, UK
  3. Hampshire Hospitals NHS Foundation Trust – Basingstoke Hospital, Basingstoke, UK
  4. West Hertfordshire Hospital NHS Trust – Hemel Hempstead Hospital, Hemel Hempstead, UK
  5. mymhealth Limited, Bournemouth, UK
  6. 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

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
Research MMH-R02

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

Rescue Study (MMH-R02) published in npj Digital Medicine on 20 October 2020

  1. my mhealth Ltd Bournemouth, UK
  2. Portsmouth Hospitals NHS Trust, Portsmouth, UK
  3. Imperial College, London, UK
  4. NIHR ARC Wessex, University of Southampton, Southampton, UK
  5. Faculty of Medicine, University of Southampton, Southampton, UK

First publication of complete results shows the myCOPD app could play an important role in supporting recovery following an exacerbation of COPD.

The results from the RESCUE trial (MMH-R02), investigating the possible impact of myCOPD in supporting the recovery of patients admitted with an exacerbation of COPD were published in NPJ Digital Medicine Journal.

Exacerbations of COPD are one of the commonest causes of admission and re-admission to hospital. The role of digital interventions to support self-management in improving outcomes is uncertain.

We conducted an open, randomised controlled trial of myCOPD 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.

Results showed the app was acceptable in this care setting and was used by 17 of the 21 patients with sustained use over the study period. The treatment effect on 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 errors).

Exacerbations tended to be less frequent in the digital arm compared to usual care; 34 vs 18 events. Hospital re-admissions risk was 30 numerically lower in the digital intervention arm: OR for readmission 0.383 (95%CI 0.074, 1.987; 31 n=35).

In this feasibility study of the digital self-management platform myCOPD, the app has proven acceptable. Its use has improved exacerbation recovery rates, with strong signals of lower re-exacerbation and re-admission 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.

Read the full paper on npj Digital Medicine
Research MMH-R01

Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial

Trooper Study (MMH-R01) published in BMJ Open on 17 July 2017

  1. Portsmouth Hospitals NHS Trust, Portsmouth, UK
  2. my mhealth Ltd Bournemouth, UK
  3. Imperial College, London, UK
  4. Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK

First publication of complete results shows a 6-week programme of online supported pulmonary rehabilitation (PR) was non-inferior to a conventional model delivered in face-to-face sessions. This study was a non-inferiority randomised control trial to compare the outcomes of an online PR programme versus conventional face to face PR, in improving physical performance and symptoms in patients with chronic obstructive pulmonary disease (COPD).

This study was a two-arm parallel single-blind, randomised controlled trial, the online arm used the online PR programme to perform PR in their own homes and the face to face arm, received conventional face to face rehabilitation in a local facility.

90 patients referred for PR, with a confirmed diagnosis of COPD and a modified Medical Research Council (MRC) score of 2 or greater were enrolled into the study. Patients were randomised, in a 2:1 ratio to receive online PR using myCOPD and 26 received conventional face to face PR. The main outcomes measured were 6-minute walk distance test and the COPD assessment test (CAT) score at completion of the programme.

The 6-week programme of online supported PR was non-inferior to a conventional model delivered in face-to-face sessions in terms of impact on the 6-minute walk test distance and symptom scores, and was safe and well tolerated by patients.

Read the full paper on
Evaluation MMH-E01

A real-world service evaluation of myHeart

18 Nov, 2020

Results of a service evaluation of myHeart and the potential benefit of using the myHeart app to supplement existing cardiac rehabilitation.

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Evaluation MMH-E02

A real-world multi-centre service evaluation of myDiabetes

18 Nov, 2020

Results have led to continued QISMET Accreditation for myDiabetes (QIS2015) and have revealed the app could play an important role in supporting structured patient education delivery for type 2 diabetes following initial diagnosis, and as an ongoing resource.

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Evaluation MMH-E03

Enhanced home-based pulmonary rehabilitation myCOPD evaluation

14 Dec, 2020

Results of a service evaluation by Southend University Hospital using myCOPD to support a home-based pulmonary rehabilitation (PR) programme in several different local locations.

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Evaluation MMH-E04

A real-world service evaluation of myCOPD

14 Dec, 2020

Results of a supported self-management evaluation of COPD patients by Stonehaven Medical Group and Aberdeenshire Health & Social Care Partnership (NHS Grampian).

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