A randomised controlled trial to explore the safety and clinical efficacy of a treatment re-alignment algorithm using data from a digital self-management application for patients with COPD
The safety and efficacy of a digital treatment guidance algorithm in patients with chronic obstructive pulmonary disease (COPD)
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 analysis to determine if the trial should continue based on whether participants follow the advice provided by the app. The focus is on adherence to the intervention guidelines. Phase 2 (Efficacy): We will evaluate the safety, acceptability, and effectiveness of the intervention. Qualitative Sub-study: Semi-structured interviews to understand how acceptable and practical the treatment approach is for participants and their healthcare providers. Consent Consent to participate in the trial will be captured through a dedicated trial website using an electronic consent (eConsent) system. Potential participants will be invited to visit the website, where they will read a brief description of the trial. If interested, they can then read the ethically approved Patient Information Sheet with a full explanation of the trial. A telephone number to contact the trial team will also be provided should the patient have any questions about the trial or the consent process. If the patient is willing to take part in the trial, the eConsent system will guide them through the eConsent process, using an ethically approved eConsent form. Once consent has been provided by the patient, an email will be sent to the participant with a copy of the PIS. Following consent, a letter informing the patient's GP of the trial and the patient's involvement will be sent. This letter will contain further information about the possibility of COPD treatment change requests by the participant whilst the patient is on the trial. Participants who agree to be contacted regarding the qualitative sub-study interviews will also give consent for their contact details to be shared with the qualitative researcher. The contact details will be accessed securely by the researcher, who will contact these patients dir
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) 6.2. Many 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) 7.2. Many 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
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