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RECRUITING
NCT07797985
PHASE1

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.

Sponsor: University of Southampton

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

746

Start Date

2025-10-08

Completion Date

2026-09

Last Updated

2026-09-01

Healthy Volunteers

Yes

Interventions

DEVICE

MMH-LAB1 app

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

Locations (1)

University Hospital Southampton

Southampton, England, United Kingdom