Digital therapy for managing COPD
Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
This study tests a digital therapy program designed to help people with COPD use their inhalers correctly and stick to their medication to see if it can reduce flare-ups and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06776601 on ClinicalTrials.gov |
What this trial studies
This project implements a comprehensive digital therapy intervention for patients with Chronic Obstructive Pulmonary Disease (COPD). It includes an inhalation technique assessment device, an electronic inhalant medication monitoring device, and digital software to help patients use their inhalers correctly. The intervention aims to enhance medication adherence, manage behavior data, and provide personalized reminders and feedback to patients. The goal is to reduce acute exacerbations of COPD and improve overall disease management.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40 and above with a diagnosis of COPD who have experienced severe exacerbations in the past year but are currently stable.
Not a fit: Patients with unstable comorbidities or recent surgeries, as well as pregnant or lactating women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence and reduce the frequency of acute exacerbations in COPD patients.
How similar studies have performed: Other studies have shown promise in using digital interventions for chronic disease management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients diagnosed with COPD 2. Aged 40 and above 3. Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks 4. Can operate a smartphone proficiently 5. Take inhalation medication suits for the inhalation monitoring device as treatment 6. Fully understand and be willing to sign the informed consent form Exclusion Criteria: 1. Certain comorbidities (e.g. unstable coronary complications) 2. Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months 3. Pregnant or lactating women 4. ABS allergy history
Where this trial is running
Beijing, Beijing Municipality
- China Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Hongtao Niu, PhD — China Japan Friendshi Hospital
- Study coordinator: Hanna Wu, MD
- Email: wuhanna0506@163.com
- Phone: 86+15827502015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.