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

NCT ID: NCT06601790

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-06

Study Completion Date

2026-05-02

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention group

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.

Group Type EXPERIMENTAL

Immediate application of the Smart Homespital system

Intervention Type BEHAVIORAL

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.

attention-waitlist control group

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.

Group Type EXPERIMENTAL

Delayed application of the Smart Homespital system after 3 months

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Division of Pulmonary and Critical Care Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Mindong Sung, PhD

Role: CONTACT

010-6554-0827

Facility Contacts

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Mindong Sung, PhD

Role: primary

010-6554-0827

Other Identifiers

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4-2024-0300

Identifier Type: -

Identifier Source: org_study_id

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