Evaluation of the Effectiveness, Safety, and Cost of a Smart Home-based Hospital System for Patients With Interstitial Lung Disease: Prospective Multicenter Randomized Controlled Trial

Yonsei University

Status: Enrolling

Conditions: Interstitial Lung Disease

Treatments: Behavioral: Delayed application of the Smart Homespital system after 3 months; Behavioral: Immediate application of the Smart Homespital system

Study type: Interventional

Funder types: Other

Identifiers

NCT06601790

4-2024-0300

Details and patient eligibility

About

This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with interstitial lung disease to easily access and use biosignals generated using biosignal collection medical equipment at home.

Enrollment: 110 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients diagnosed with COPD who meet the following pulmonary function test results:

1. Pre FEV1 < 80% **or**
2. Pre FVC < 80% **or**
3. DLCO < 60%

Exclusion criteria

1. Patients who do not agree to participate in the study.
2. Patients who fail to use the medical device equipment.
3. Patients where tracking during the study period is expected to be impossible.
4. Patients who have difficulty communicating verbally.
5. Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
6. Patients receiving hospital-centered rehabilitation treatment during the study period.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

intervention group

Experimental group

Description:

The Smart Homespital system can be applied for the first 3 months (12 weeks), and then the primary and secondary variables will be evaluated at 3, 6, 9months.

Treatment:

Behavioral: Immediate application of the Smart Homespital system

attention-waitlist control group

Experimental group

Description:

The waiting list-control group will receive general medical services for the first 3 months and will receive the Smart Homespital system for 3-6 months. Primary and secondary variables will be evaluated between 3, 6, and 9 months.

Treatment:

Behavioral: Delayed application of the Smart Homespital system after 3 months