Ireland
--:--IST
Recruiting Not applicable

Digital Therapy in Self-management of COPD Patients

NCT06776601 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2024-07-18
Last updated
2025-01-15

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Full process digital therapy intervention package

Full process digital therapy intervention package: Patients will receive individualized inhalation skills guidance after being tested by inhalation capacity measuring device, and be equipped with electronic inhalation monitoring devices, which can record their medication using data, reminding patients to use the medication on time, and correct their inhalation mistake. They can also check their inhalation record on their mobile phones. Clinicians can check the record every month to assess their adherence.

Study summary

This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • severe exacerbation — 12 month
    Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.

Trial sites (1)

FacilityCityRegionStatus
China Japan Friendship Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06776601 on ClinicalTrials.gov ↗ ← All trials in Japan