Digital Therapy in Self-management of COPD Patients

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Full process digital therapy intervention package

Study type: Interventional

Funder types: Other

Identifiers

NCT06776601

ZRJY2023-QM16

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

600 participants in 2 patient groups

Digital therapy intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Full process digital therapy intervention package

General management group

No Intervention group

Description:

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