Digital Therapeutics on Inhalation Medication Adherence in COPD

NCT05667363 | Unknown

• 1 other identifier: 2022-HX-43
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Digital Intervention; Inhalation Medication; Adherence

Outcome Measures

Primary Outcomes (1)

• Proportion of adherent patients.

  The proportion of patients whose TAI scores 50.

  24 weeks

Secondary Outcomes (1)

• Average times of AECOPD

  4, 12 ,24 weeks

Study Arms (2)

Digital Intervention

EXPERIMENTAL

Accept metered-dose inhaler medication treatment equipped with digital therapeutics consist of smartphone app and 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.

Combination Product: Digital Intervention

Usual use

NO INTERVENTION

Accept regular metered-dose inhaler medication treatment.

Interventions

Digital Intervention COMBINATION_PRODUCT

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.

Digital Intervention

Eligibility Criteria

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

You may qualify if:

• Fully understand and willing to sign the written informed consent;
• Local residents diagnosed COPD by physician;
• Aged 40 and above;
• Plan to receive metered-dose inhaler as long-term treatment;
• Have a smartphone and can apply WeChat applet after training;

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, 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

• Ting Yang, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Yang, MD

CONTACT

84206272; zryyyangting@163.com

Study Design

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

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 28, 2022
• Study Start: December 20, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

CN (1)