mySmartCOPD V1
Research type
Research Study
Full title
A randomised controlled trial to explore the safety and clinical efficacy of a treatment re-alignment algorithm using data from a digital self-management application for patients with COPD
IRAS ID
355764
Contact name
Tom Wilkinson
Contact email
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a common, globally important long-term lung condition that affects the lives of millions of people worldwide. Symptoms include breathlessness, cough and wheeze often making it difficult to carry out everyday activities. In the UK, COPD is responsible for 130,000 annual hospital admissions, and approximately 30,000 people die each year, many prematurely due to fatal exacerbations (flare-ups).
COPD cannot be cured but it is treatable with inhaled medication. Optimal medication management provides symptom control, slows disease progression, and aims to improve quality of life. However, despite the availability of national and international evidence-based guidelines, research has shown COPD treatment is not always prescribed according to recommendations. Poor adherence to guidelines and underdiagnosis means patients continue to experience symptoms regardless of the treatment they are taking. Furthermore, adherence to treatment or poor inhaler technique significantly impact COPD health outcomes.
To address this, my mhealth Ltd and the University of Southampton created a digital tool to observe whether people using a digital self-management application (app) ‘myCOPD’ were receiving guideline-based inhaler treatment. This tool uses a treatment realignment algorithm to compare app user reported inhaler use against COPD Assessment Test (CAT) scores, symptoms, and exacerbation history. The algorithm has been designed to follow the GOLD 2023 guidelines for COPD management.
The algorithm has been tested using retrospective data (Proportionate Review Approval – IRAS: 320723; REC reference: 22/PR/1722). We will now test the algorithm in a prospective randomised controlled trial called ‘mySmartCOPD’. This trial will use two versions of an app called ‘MMH-LAB1’:
• Control Arm: This version, called MMH-LAB_Control_1, does not include the algorithm.
• Intervention Arm: This version, called MMH-LAB_Test_1, includes the algorithm.MMH-LAB1 is only for use in the mySmartCOPD clinical trial, and is clearly marked with a banner stating, ‘Exclusively for Research Use only’.
The aim is to observe whether the algorithm can:
1. Identify when a participant’s inhaler treatment does not adhere to GOLD 2023 guidelines.
2. Prompt participants to visit their healthcare team for a medication review if they receive an out of guidance message.
3. Support participants to understand their symptoms, flare-up history and risk based on their CAT score.The trial 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 either the Intervention Arm or the Control Arm ‘MMH-LAB_Control_1’. Participants in both Arms will receive additional research questionnaires. Those in the Intervention Arm will have access to a Patient Advocate to support them during the trial should they need it.
If the algorithm identifies that a participant in the Intervention Arm is not on the correct medication, the app will notify them to contact their healthcare team for a medication review. The notification will include details of their symptoms and current medication to support their healthcare team during the review.
Study Phases
The trial will be conducted in three phases:
1. Phase 1 (Pilot): The first 50 participants will test whether the advice from the algorithm is followed.
2. Phase 2 (Efficacy): This phase will include all 746 participants (including the 50 from Phase 1) and will assess how safe, effective, and acceptable the intervention is.
3. Qualitative Sub-study: Around 15-20 participants and Patient Advocates will be interviewed to explore how acceptable and useful the intervention is.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
25/WM/0050
Date of REC Opinion
25 Mar 2025
REC opinion
Favourable Opinion