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RECRUITINGINTERVENTIONAL

Evaluation of the Effectiveness, Safety, and Cost of a Smart Hospital System for Patients With Chronic Obstructive Pulmonary Disease

Evaluation of the Effectiveness, Safety, and Cost of a Smart Hospital System for Patients With Chronic Obstructive Pulmonary Disease: Prospective Multicenter Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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% Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Severance Hospital
Seoul, South Korea