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NCT Number: NCT06601790

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Pulmonary and Critical Care Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with COPD who meet the following pulmonary function test results:

  • Pre FEV1 < 80% **or**
  • Pre FVC < 80% **or**
  • DLCO < 60%

Exclusion criteria

  • Patients who do not agree to participate in the study.
  • Patients who fail to use the medical device equipment.
  • Patients where tracking during the study period is expected to be impossible.
  • Patients who have difficulty communicating verbally.
  • Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
  • Patients receiving hospital-centered rehabilitation treatment during the study period.

Treatment and study plan

Immediate application of the Smart Homespital system

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.

Delayed application of the Smart Homespital system after 3 months

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.

Primary outcomes

  1. Respiratory symptom questionnaire

    Time frame: 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.

    • 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

Secondary outcomes

  1. Depression Questionnaire

    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.

    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

  2. Service satisfaction evaluation

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

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

  3. safety

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

    • 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.

  4. cost assessment

    Time frame: After study ends (9 months later)

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

  5. 6 minute walking test

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

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

  6. pulmonary function test

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

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

  7. system compliance

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

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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