To Identify if a COPD Self-management App Can Safety and Appropriately Identify When Patients Are Not on the Best Medication Plan for Their COPD Symptoms and Support Their COPD Management.

To Explore the Safety and Clinical Efficacy of a Treatment Realignment Algorithm Using Data From a Digital Self-management Application for Patients With COPD

Although COPD cannot be cured, managing COPD can help reduce symptoms control, slows progression of the disease, and may improve the quality of life. Management of COPD becomes less effective when healthcare professionals fail to prescribe appropriate inhaled therapies, due to poor adherence to evidence-based guidelines and underdiagnosis, or when patients fail to adhere to prescribed treatment regimens.

my mhealth has developed an app called myCOPD to allow patients to record their COPD symptoms and medications, which in term supports them with their COPD. This app is now used by COPD patients across the UK, via a prescription from their healthcare professionals. my mHealth has now developed a research app MMH-LAB1 which, in the intervention arm, includes an algorithm to assist patients with understanding their level of symptom burden according to the severity of their daily symptoms and exacerbation risk. The algorithm then analyses current patient prescribed inhaled medication against those recommended by the GOLD 2023 report and informs the patient via the MMH-LAB1 app as to whether their medication needs to be changed by their healthcare provider. This trial will explore whether the introduction of the algorithm within the MMH-LAB1 app can be used as a safe, effective and acceptable tool to assist patients to achieve optimal guideline based inhaled therapy and therefore provide greater symptom control and lowered exacerbation risk for COPD patients.

Participants will be randomised to the MMH-LAB1 app - control arm (MMH-LAB_Control_1 where participants just record COPD symptoms and medications), or to the MMH_LAB1 app - intervention arm (MMH-LAB1_Test_1 where participants record their COPD symptoms and medication plus receiving information from the algorithm, as to whether their medications are in guidance or not, and if not, be notified to visit their healthcare professional.

This study is an open-label randomised control trial with inbuilt pilot phase and qualitative sub-study:

Phase 1 (pilot - 50 participants): Interim futility analysis on adherence to intervention advice Phase 2 (efficacy - 746 participants (including pilot phase participants): Safety acceptability and efficacy of intervention. This includes the qualitative sub study 15-20 participants (from the 746 Phase 2 participants).

Qualitative Sub-study: Acceptability of the intervention (15-20 intervention participants)

This trial will explore whether the introduction of the treatment realignment algorithm can be used as a safe, effective and acceptable tool to assist patients to achieve optimal, guideline based inhaled therapy and therefore provide greater symptom control and lowered exacerbation risk for COPD patients. To assess effect of the intervention on patients' symptom control, including exacerbation frequency and patient wellness scores.

Main objectives

• To understand the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality
• To assess the levels of app usage and engagement
• To assess patients' experience of using the intervention

Study Design:

Open-Label Randomised Control Trial with inbuilt pilot phase Qualitative Sub study:

Phase 1 (Pilot): Interim futility analysis on adherence to intervention advice Phase 2 (Efficacy): Safety, acceptability and efficacy of intervention Qualitative Sub-study: Acceptability of the intervention.

The research question is to explore the safety and efficacy of the treatment re-alignment algorithm as part of a digital self-management application (app) in patients with COPD.

Inclusion Criteria:

1. Adult patients over 18 years of age and able to give informed consent

2. A clinical diagnosis of COPD (all patients registered on the app have a confirmed diagnosis of COPD confirmed by their clinician before being prescribed the app).

3. A registered and activated user of the myCOPD app

4. One or more CAT questionnaire completed on the myCOPD app in the last 12 months

5. One or more exacerbation form completed on the myCOPD app in the last 12 months CTU/FORM/5321 - CIP template for Clinical Investigations of Medical Devices, Version 1 14-DEC-2023 mySmartCOPD Clinical Investigation Plan v1 25-FEB-2025 Page 25 of 53

6. One or more COPD medication diary completed on the myCOPD app in the last 12 months

7. Classified appropriately into 3 groups:

   (A) Few symptoms (CAT <10, 0 or 1 moderate exacerbations) (B) Many symptoms (CAT ≥10, ≥0 or 1 moderate exacerbations) (C)Exacerbators (≥2 moderate or ≥1 severe exacerbation independent of CAT)

   Exclusion Criteria:

8. Cannot read or write in English as required to understand the trial materials and provide the trial data.

9. Has not opted in to the research agreement via MyCOPD