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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.

RecruitingPhase 1Ages 18 Years - anyAllUniversity of Southampton
NCT07797985 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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
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What it tests

  • MMH-LAB1 app
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Where

1 site
University Hospital Southampton
Southampton, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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