Digital Therapy in Self-management of COPD Patients

NCT ID: NCT06776601

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Full process digital therapy intervention package

Intervention Type 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.

General management group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongtao Niu

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hongtao Niu, PhD

Role: PRINCIPAL_INVESTIGATOR

China Japan Friendshi Hospital

Locations

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China Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hanna Wu, MD

Role: CONTACT

86+15827502015

Hongtao Niu, PhD

Role: CONTACT

86+15810610306

Facility Contacts

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Hanna Wu, MD

Role: primary

86+15827502015

Other Identifiers

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ZRJY2023-QM16

Identifier Type: -

Identifier Source: org_study_id

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