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.

NCT07797985 | Recruiting Phase 1 DMC

• 2 other identifiers: 355764AI_Award02200
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiration Disorders

Keywords

Chronic Obstructive Pulmonary Disorder

Outcome Measures

Primary Outcomes (1)

• To determine the safety, acceptability and efficacy of a digital treatment guidance algorithm for inhaled treatment in patients with COPD. The intention is to measure the impact of the algorithm in prompting patients to achieve optimal management, and t

  Proportion (measured in %) of participants receiving guideline adherent treatment at Baseline and trial completion (Month 6). Range 0%-100%.

  6 months

Secondary Outcomes (8)

• To assess effect of intervention on exacerbation frequency and patient wellness scores

  6 months

• To assess effect of the intervention on patients' adherence to guideline mandated treatment

  6 months

• To understand the utility of the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase in order to maximise healthcare equality

  6 months

• To assess the levels of app algorithm usage and engagement

  6 months

• To understand patients' experience of using the intervention

  3-6 months - interviews. 6 months - feedback questionnaire

Study Arms (2)

MMH-LAB1 Control This arm is based on the original COPD app the participants already use

PLACEBO COMPARATOR

Participants for this study are already users of a COPD self management app. This arm is a replica of this app, with additional questionnaires built in

Device: MMH-LAB1 app

MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithm

EXPERIMENTAL

Participants for this study are already users of a COPD self management app. This arm is a replica of this app, with additional questionnaires built in plus an algorithm which identifies, based on the symptoms and medication reported onto the app by the participant, whether they are on the correct medication or not. If not, the app will generate a notification and inform the participant that they need to approach their healthcare provider and inform them of this and that they need a medication review.

Device: MMH-LAB1 app

Interventions

MMH-LAB1 app DEVICE

This app is based on a COPD self management app, which they are already using and includes an algorithm which will notify participants if there is a discrepancy between the symptoms they report onto the app and their medication regime, and informs them to approach their healthcare provider for a medication review

MMH-LAB1 Control This arm is based on the original COPD app the participants already use; MMH-LAB1 Test This arm is based on the original COPD app the participants use plus an algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years of age and able to give informed consent
• 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).
• A registered and activated user of the myCOPD app
• One or more CAT questionnaire completed on the myCOPD app in the last 12 months
• 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
• One or more COPD medication diary completed on the myCOPD app in the last 12 months
• 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)

You may not qualify if:

• Cannot read or write in English as required to understand the trial materials and provide the trial data.
• Has not opted in to the research agreement via MyCOPD

Sponsors & Collaborators

• University of Southampton: lead

Study Sites (1)

University Hospital Southampton

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Trial Manager

CONTACT

+44 23 8059 6920; mysmartcopd@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial of an interventional device

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: September 1, 2026
• Study Start: October 8, 2025
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-05

Locations

GB (1)