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Active, not recruitingNCT06601790Updated Jul 7, 2026

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

An interventional study of Immediate application of the Smart Homespital system and Delayed application of the Smart Homespital system after 3 months in Interstitial Lung Disease, sponsored by Yonsei University. Active, not recruiting at 1 site in South Korea. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Yonsei University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

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.

02

Conditions studied

  • Interstitial Lung Disease
03

In context

Lung Diseases, Interstitial

646 studies on the registry are indexed under Lung Diseases, Interstitial; 237 are open to participants now.

This study's enrollment of 83 is above the median of 54 across 355 interventional studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Immediate application of the Smart Homespital system

  • Experimental
    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.

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

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.

06

What researchers measure

Primary outcomes

  1. Respiratory symptom questionnaire

    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

    Time frame: After applying the Smart Homespital system(12weaks)

Secondary outcomes

  1. Depression Questionnaire

    K-CESD-R : Survey every 2 weeks during the 12-week Homespital system application, then at 3, 6, and 9 months after the start of the study. * Success Criteria: Achieving 4 points or more. * Success: 4 points or more

    Time frame: Survey every 2 weeks during the 12-week Homespital system application, then at 3, 6, and 9 months after the start of the study.

  2. Service satisfaction evaluation

    * CSQ-8: After 12 weeks of applying the Smart Homespital system. * Success Criteria: Achieving 4 points or more.

    Time frame: After 12 weeks of applying the Smart Homespital system.

  3. safety

    * Number of hospital visits directly related to the Smart Home Hospital Program * Success Criteria: Less than 2 hospital visits related to the Smart Homespital program.

    Time frame: Measured after the study ends (9 months later).

  4. cost assessment

    \- Criteria: Comparison of average hospital respiratory rehabilitation treatment costs with the Smart Homespital program's costs.

    Time frame: After study ends (9 months later)

  5. 6 minute walking test

    \- Success Criteria: More than a 10% increase over the baseline.

    Time frame: At 3, 6, and 9 months.

  6. pulmonary function test

    \- Success Criteria: Increase in FVC, FEV1, or DLCO by more than 10% at the time of registration.

    Time frame: At 3, 6, and 9 months.

  7. system compliance

    -Criteria: Maintaining a minimum of 5,000 steps/day during the 12-week period of applying the Homespital system.

    Time frame: During the 12-week period of applying the Homespital system.

07

Study locations

1 site
  • Division of Pulmonary and Critical Care Medicine
    Seoul, 03722, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06601790
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 5, 2024
Primary completion
Apr 20, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Jul 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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