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

NCT06601790 · tracked via the Priya Life Science South Korea tracker

Sponsor

Yonsei University

Phase

Not applicable

Started

2024-09-05

Last updated

2026-07-07

Condition(s) studied

Interstitial Lung Disease

Investigational drug(s) / intervention(s)

Immediate application of the Smart Homespital systemDelayed application of the Smart Homespital system after 3 months

Immediate application of the Smart Homespital system: 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. While applying the Smart Homespital system, exercise three times a week, measure sleep twice a week, and questionnaire assessments (mMRC, CRQ, EQ-5D, K-CESD) are conducted once every two weeks.

Delayed application of the Smart Homespital system after 3 months: The waiting list-control group will receive general medical services for the first 3 months and will receive a Smart Homespital system for 3-6 months. Primary and secondary variables will be monitored between 3, 6, and 9 months. While applying the Smart Homespital system, exercise three times a week, measure sleep twice a week, and questionnaire assessments (mMRC, CRQ, EQ-5D, K-CESD) are conducted once every two weeks.

Study summary

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.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

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.

Primary outcome measure(s)

Respiratory symptom questionnaire — After applying the Smart Homespital system(12weaks)
For survey scores, success is defined as an increase in the respective defined MCID(the minimal clinically important difference) rises the baseline. 1\) Chronic respiratory questionnaire (CRQ) * Success: 4 points or more 2.)Modified Medical Research Council dyspnea scale (mMRC) * Success: 1points or more 3) EQ-5D * Success: 1 points or more

Trial sites (1)

Facility	City	Region	Status
Division of Pulmonary and Critical Care Medicine	Seoul	South Korea

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06601790 on ClinicalTrials.gov ↗ ← All trials in South Korea