RecruitingNot ApplicableNCT06601777

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


Sponsor

Yonsei University

Enrollment

198 participants

Start Date

Sep 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a "smart hospital" digital health system — which monitors patients with COPD (chronic obstructive pulmonary disease) remotely using connected devices — can improve care, safety, and cost-effectiveness compared to usual care. **You may be eligible if...** - You have been diagnosed with COPD - Your breathing tests show significant impairment (reduced lung function on spirometry or low lung diffusion capacity) **You may NOT be eligible if...** - You decline to participate - You are unable to use the medical device equipment required for the study - You are expected to be unavailable or difficult to follow up during the study period - You have difficulty communicating verbally - You are bedridden or completely unable to exercise due to severe heart or breathing problems - You are currently receiving a hospital-based rehabilitation program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALImmediate 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.

BEHAVIORALDelayed 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

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NCT06601777


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