mySmartCOPD V2
Research type
Research Study
Full title
A randomised controlled study to explore the safety and efficacy of the mySmartCOPD treatment re-alignment algorithm as part of a digital self-management app in patients with COPD.
IRAS ID
324487
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Although Chronic Obstructive Pulmonary Disease (COPD) cannot be cured, optimal management provides symptom control, slows progression of the disease, and may improve the quality of life. Management of COPD becomes suboptimal when physicians fail to prescribe appropriate therapies, due to poor adherence to evidence-based guidelines and under-diagnosis, or when patients fail to adhere to prescribed treatment regimens.
My mhealth have developed an algorithm (mySmartCOPD) to assist patients with understanding their level of symptom burden according to results from the COPD Assessment Test (CAT), exacerbation risk based on the combination of current GOLD grouping and the exacerbation risk profiling of the myCOPD app population that falls within this group. The algorithm then analyses current patient prescribed medication against GOLD 2023 guidelines.
This trial will explore whether the introduction of the mySmartCOPD algorithm to the myCOPD app can be used as a safe, effective and acceptable tool to assist patients to achieve optimal, guideline based therapy and therefore provide greater symptom control and lowered exacerbation risk for COPD patients using the app.
We will recruit 746 existing users of the myCOPD app over a six-month recruitment period with participation lasting six months. Participants will be randomised to receive the mySmartCOPD algorithm result within their myCOPD app (intervention); or will not receive the result and continue using the myCOPD app with additional research questionnaires (control). Data entered by participants will be run through the mySmartCOPD algorithm with intervention patients being notified of the result via in-app notification. If the algorithm identifies that the participant is not on medication in accordance with GOLD 2023 guidelines, the notification will request that the participant see their healthcare team for a COPD medication review. Patients symptoms and current prescribed medication will be presented to the healthcare team by the participant via the notification to aid the medication review.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0067
Date of REC Opinion
23 Apr 2024
REC opinion
Favourable Opinion