Digital Therapy in Self-management of COPD Patients

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06776601
• Lead Sponsor: China-Japan Friendship Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Study First Submitted: 2024-12-21
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-09-18
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
severe exacerbation	12 month	Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.

Secondary Outcome Measures

Name	Time	Method
First Second Forced Expiratory Volume/ Forced Vital Capacity	12 month	First Second Forced Expiratory Volume/Forced Vital Capacity (FEV1/FVC) measured by pulmonomete, %
First Second Forced Expiratory Volume percentage of estimated	12 month	First Second Forced Expiratory Volume (FEV1) percentage of estimated measured by pulmonomete, %
peak expiratory flow	12 month	peak expiratory flow (PEF) measured by pulmonomete, L/min
COPD Assessment Test score	12 month	COPD assessment test (CAT) is an eight-item questionnaire range from 0 to 40. Higher scroe represents heavier symptom.
modified Medical Research Council scale	12 month	The modified Medical Research Council (mMRC) scale stands for the level of patient self-report dyspnea. 0 is the minimum and 4 is the maximum.
St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score	12 month	the SGRQ scroe range from 0 to 100. 0 represents for the least and 100represents for the most.
peak inspiratory flow rate	12 month	peak inspiratory flow rate (PIFR) measured by the sensor in the study
mild and moderate exacerbation	12 month	Proportion of patients with mild and moderate acute exacerbation of COPD pulmonary disease during the follow-up period.

Trial Locations

Locations (1)

China Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China