Digital Therapy in Self-management of COPD Patients

NCT06776601 | Recruiting

• 1 other identifier: ZRJY2023-QM16
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; adherence; inhaled medication; self management

Outcome Measures

Primary Outcomes (1)

• severe exacerbation

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

  12 month

Secondary Outcomes (8)

• First Second Forced Expiratory Volume/ Forced Vital Capacity

  12 month

• First Second Forced Expiratory Volume percentage of estimated

  12 month

• peak expiratory flow

  12 month

• COPD Assessment Test score

  12 month

• modified Medical Research Council scale

  12 month

Study Arms (2)

Digital therapy intervention group

EXPERIMENTAL

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.

Behavioral: Full process digital therapy intervention package

General management group

NO INTERVENTION

Patients will accept regular inhaler medication direction, and equipped with electronic inhalation monitoring that can only record medication using data.

Interventions

Full process digital therapy intervention package BEHAVIORAL

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.

Digital therapy intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Certain comorbidities (e.g. unstable coronary complications)
• Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months
• Pregnant or lactating women
• ABS allergy history

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongtao Niu, PhD

  China Japan Friendshi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Wu, MD

CONTACT

86+15827502015; wuhanna0506@163.com

Hongtao Niu, PhD

CONTACT

86+15810610306; oxhongtao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 15, 2025
• Study Start: July 18, 2024
• Primary Completion: September 18, 2025
• Study Completion: December 30, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)