Personalized mobile app warnings to reduce COPD flares

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a cluster-randomized study conducted at four hospitals in Beijing, where hospital sites are randomized to either receive the temperature-risk app alongside usual COPD care or usual care alone. The app uses real-time weather data and individual factors to generate warnings and protective guidance for participants. Participants are adults with stable COPD who have recent exacerbations and own a smartphone, followed for 12 months with visits at baseline, 3, 6, 9, and 12 months. Outcomes include acute exacerbations, quality of life, functional capacity, symptoms, psychological status, physiological/biochemical indicators, and user engagement with the app.

Why it matters

Who can join: the full rules

Hospital inclusion criteria:

1. Tertiary hospitals;
2. Hospitals with respiratory wards that admit patients with COPD;
3. Hospitals with a well-established electronic health record system and follow-up capability;
4. Hospitals able to assign a study coordinator.

Patient inclusion criteria:

1. Age \>=40 years and \<=80 years, with no restriction on sex;
2. Patients with stable chronic obstructive pulmonary disease;
3. At least 1 severe acute exacerbation requiring hospitalization, or at least 2 moderate acute exacerbations requiring outpatient or emergency care, within the previous year;
4. Local permanent residents with a duration of residence \>=6 months;
5. Patients who voluntarily agree to participate, are expected to have good adherence, are able to sign informed consent;
6. Patients who own a smartphone or other smart device.

Hospital exclusion criteria:

1. Primary hospitals or private hospitals;
2. Hospitals unable to cooperate with the study protocol.

Patient exclusion criteria:

1. Patients with asthma;
2. Women who are known to be pregnant or breastfeeding, or who have a positive pregnancy test before cluster randomization;
3. Patients with other diseases that may affect participation in the trial, such as refractory hypertension or severe aphasia;
4. Patients currently receiving psychiatric or psychological treatment that may contaminate study results;
5. Expected survival time \<1 year, such as in those with malignant tumors or severe cardiopulmonary disease;
6. Participation in other interventional clinical studies that may affect outcome assessment;
7. Any other circumstances in which the investigator considers the patient unsuitable for participation in this study or at significant risk, such as cognitive impairment preventing understanding of and/or compliance with study procedures and/or follow-up.

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, China Recruiting
• Beijing Huairou Hospital
  Beijing, China Recruiting
• Civil Aviation General Hospital
  Beijing, China Recruiting
• Emergency General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Can Zhang, Ph.D.
• Email: zhangcan@nieh.chinacdc.cn
• Phone: +8613655181384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.