Digital Therapeutics on Inhalation Medication Adherence in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effect of a Digital Therapeutics Program on Inhaled Medication Adherence in Patients With Chronic Obstructive Pulmonary Disease：a Prospective, Open-label, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667363
• Other study ID #: 2022-HX-43
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2022
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang, MD
• Phone: 84206272
• Email: zryyyangting[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Digital Therapeutics (DTx) is an evidence-based，clinically evaluated software to treat，manage，and prevent a broad spectrum of diseases and disorders according to Digital Therapeutics Alliance，which may improve the adherence of patients with chronic obstructive pulmonary disease (COPD) to use inhaled medication and reduce the risk of acute exacerbation. This study plans to carry out a randomized controlled trial (RCT), using digital therapy to record and manage the behavior data of patients with COPD in the process of using inhaler medication, and analyze the correlation between digital therapy of COPD and patients' drug compliance and treatment effect.

Description:

Chronic obstructive pulmonary disease (COPD) is a major disease that causes death and disability worldwide. The World Health Organization (WHO) estimates that COPD has become the third leading cause of death worldwide, accounting for 6% of the global total deaths in 2019. COPD seriously affects the quality of life of patients and causes heavy economic burden to society and families.

Inhaled medication is the key treatment for COPD, and the adherence of inhaled medication is closely related to the effect of disease control. Studies have shown that incorrect and irregular use of metered-dose inhaler are very common in patients.Previous studies have shown that patients using mobile phones to record respiratory symptom diaries, and send blood oxygen saturation, heart rate, body temperature and other data, as well as changes in medication and medical treatment to the portal, and doctors access the data online to identify potential acute exacerbation and take intervention measures, can reduce the risk of acute exacerbation of COPD.

The digital therapeutics of COPD consists of patient mobile phone program, doctor management software and intelligent medication recorder. It develops a digital intervention plan for patients, helping patients intuitively and comprehensively understand the treatment plan and how to act through medication tracking reminder. It also helps doctors to view visualized patient medication, symptoms and other trend data online to understand the real treatment response of patients. This study take digital therapeutics as intervention to explore the correlation between digital therapy and patient medication adherence and treatment effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 582
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Fully understand and willing to sign the written informed consent;

2. Local residents diagnosed COPD by physician;

3. Aged 40 and above;

4. Plan to receive metered-dose inhaler as long-term treatment;

5. Have a smartphone and can apply WeChat applet after training;

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• Digital Intervention
Digital therapeutics are consist of a smartphone app and an intelligent medication recorder. The intelligent medication recorder can automatically record medication using data and reminds patients through the app. Patients can also record their symptom on the app for doctors to monitor.

Locations

Country	Name	City	State
China	China-Japan Friendship hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adherent patients.	The proportion of patients whose TAI scores 50.	24 weeks
Secondary	Average times of AECOPD	The average times of self-reported history of AECOPD since the last follow-up	4, 12 ,24 weeks