The safety and efficacy of a digital treatment guidance algorithm in patients with chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
Design
An open-labelled randomised controlled trial with a qualitative sub-study, designed to test a new approach to managing COPD inhaled treatment medication.
Phase 1 (Pilot): An interim futility a
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 20/02/2026: 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 questionnaires completed on the myCOPD app in the last 12 months 5. One or more exacerbation forms completed on the myCOPD app in the last 12 months 6. Classified appropriately into 3 groups: 6.1. Few symptoms (CAT = 10, > = 0 or 1 moderate exacerbations within the last 12 months) 6.3. Exacerbators (> = 2 moderate or > = 1 severe exacerbation independent of CAT within the last 12 months) 7. Existing opt-in to research agreement to be completed by the patient Previous key 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 questionnaires completed on the myCOPD app in the last 12 months 5. One or more exacerbation forms completed on the myCOPD app in the last 12 months 6. One or more COPD medication diaries completed on the myCOPD app in the last 12 months 7. Classified appropriately into 3 groups: 7.1. Few symptoms (CAT = 10, > = 0 or 1 moderate exacerbations within the last 12 months) 7.3. Exacerbators (> = 2 moderate or > = 1 severe exacerbation independent of CAT within the last 12 months) 8. Existing opt-in to research agreement to be completed by patient
Exclusion criteria
Exclusion criteria: 1. Cannot read or write in English as required to understand the trial materials and provide the trial data. 2. Has not opted in to the research agreement via myCOPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients (frequency and %) receiving guideline adherent treatment measured using data that will be collected via the intervention (MMH-LAB_Test_1) and control (MMH-LAB_Control_1) apps at baseline and trial completion (month 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed using data collected via the intervention (MMH-LAB_Test_1) and control (MMH-LAB_Control_1) and the methods stated: 1. The effect of the intervention on patients’ adherence to guideline-mandated treatment measured using the following methods by frequency and % of daily: 1.1. Rate of algorithm indication to change treatment 1.2. Response to treatment change indication 1.3. Nature of treatment change 2. The effect of the intervention on exacerbation frequency and patient wellness scores measured using the following methods by mean, SD, median and range, frequency and % for exacerbations at baseline and 6 months: 2.1. Change in COPD Assessment Test (CAT) score 2.2. Exacerbation frequency 2.3. Change in quality of life ratings measured using the EQ-5D questionnaire 3. The feasibility of the intervention pathway in the pilot phase and to identify additional patient support mechanisms for the efficacy phase to maximise healthcare equality, measured using the following methods by frequency and percentage or description at baseline and month 6, unless mentioned below in brackets: 3.1. % Patients receiving guideline-adherent treatment 3.2. Rate of app indication to change treatment 3.3. Response to treatment change indication (measured intermittently, depending on when the participant goes out of guidance) 3.4. Nature of treatment change (Measured intermittently – depending on when a participant goes out of guidance) 4. The level of the app with algorithm usage and engagement measured using the following methods by frequency and percentage. Measurement timepoint – see below in brackets: 4.1 Frequency of app engagement (daily) 4.2. Rate of completion of endpoint data (6 months) 4.3. Resource requirement to allow patients to act on intervention information (intermittently, depending on when the participant goes out of guidance) 5. The understanding of the participants' and PAs' experiences of using the app wil | — |
Countries
England, United Kingdom
Contacts
Public ContactTom Wilkinson
Outcome results
None listed