Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients:A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Patients diagnosed with COPD

• Aged 40 and above

• Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks

• Can operate a smartphone proficiently

• Take inhalation medication suits for the inhalation monitoring device as treatment

• Fully understand and be willing to sign the informed consent form

Locations
Other Locations
China
China Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Hanna Wu, MD
wuhanna0506@163.com
86+15827502015
Backup
Hongtao Niu, PhD
oxhongtao@163.com
86+15810610306
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 600
Treatments
Experimental: Digital therapy intervention group
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.
No_intervention: General management group
Patients will accept regular inhaler medication direction, and equipped with electronic inhalation monitoring that can only record medication using data.
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov