mySmartCOPDCOPD Management with myCOPD App and Medication Realignment Algorithm
This study aims to evaluate the safety, acceptability, and effectiveness of a digital treatment guidance algorithm for inhaled treatment in patients with COPD, with the goal of measuring its impact in helping you achieve optimal management.
Enhanced COPD Self-Management App
+ Enhanced COPD Self-Management App
Respiratory Tract Diseases
+ Respiration Disorders
Supportive Care Study
Summary
Study start date: October 8, 2025
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.746 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Hospital Southampton
Southampton, United KingdomOpen University Hospital Southampton in Google Maps