Digital Therapy in Self-management of COPD Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Full process digital therapy intervention package

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Wu, MD; Phone Number: 86+15827502015; Email: wuhanna0506@163.com
• Study Contact Backup: Name: Hongtao Niu, PhD; Phone Number: 86+15810610306; Email: oxhongtao@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China Japan Friendship Hospital
      • Contact: Hanna Wu, MD; Phone Number: 86+15827502015; Email: wuhanna0506@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe exacerbation	Proportion of patients with severe acute exacerbation of COPD pulmonary disease during the follow-up period.	12 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Hongtao Niu, PhD, China Japan Friendshi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2024
• Primary Completion (Estimated): September 18, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: adherence; self management; Chronic obstructive pulmonary disease; inhaled medication
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ZRJY2023-QM16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No