Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID06776601

Digital Therapy for Self-Management of Chronic Obstructive Pulmonary Disease Patients A Prospective, Open-Label, Randomized Controlled Study

Led by China-Japan Friendship Hospital · Updated on 2025-01-15

600

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a digital therapy intervention designed to help patients with chronic obstructive pulmonary disease (COPD) better manage their condition. This approach includes tools to assess inhalation technique, monitor inhalant medication use electronically, and guide patients with personalized feedback. The goal is to see if this digital program can reduce the frequency of severe COPD flare-ups, improve disease management, and decrease the overall burden of COPD by enhancing medication adherence. The intervention involves a complete digital therapy package that starts with testing inhalation capacity to provide tailored guidance on inhaler use. Patients receive electronic devices that track their inhalation medication usage, provide reminders for timely doses, and correct mistakes in inhalation technique. They can view their inhaler use records on their smartphones, while clinicians review monthly data to evaluate adherence. Participants will be involved in monitoring their inhalation behavior through digital devices and smartphone apps. Researchers will track the number of severe COPD exacerbations over 12 months as the primary outcome. The study includes ongoing assessments of medication use, adherence, and inhalation technique, supported by monthly clinician reviews. The total duration of participation is at least one year, focusing on improving patient self-management and reducing exacerbations.

CONDITIONS

Official Title

Digital Therapy in Self-management of COPD Patients

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with COPD
  • Age 40 years or older
  • One or more severe acute exacerbations in the past year and stable condition for the last 4 weeks
  • Proficient in using a smartphone
  • Taking inhalation medication suitable for the inhalation monitoring device
  • Fully understand and willing to sign the informed consent form
Not Eligible

You will not qualify if you...

  • Unstable coronary complications or other certain comorbidities
  • Thoracic, abdominal, or ophthalmic surgery within the past 3 months
  • Pregnant or lactating women
  • History of ABS allergy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

H

Hanna Wu, MD

H

Hongtao Niu, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Frequently Asked Questions

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Digital Therapy for Self-Management of Chronic Obstructive Pulmonary Disease Patients A Prospective, Open-Label, Randomized Controlled Study | DecenTrialz