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

Not Applicable

Recruiting

• Conditions: Interstitial Lung Disease

• Registration Number: NCT06601790
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-06
• Study First Submitted: 2024-09-08
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-05-02
• Study Completion: 2026-05-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory symptom questionnaire	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.; 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

Secondary Outcome Measures

Name	Time	Method
Service satisfaction evaluation	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.
Depression Questionnaire	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
safety	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.
cost assessment	After study ends (9 months later)	- Criteria: Comparison of average hospital respiratory rehabilitation treatment costs with the Smart Homespital program's costs.
6 minute walking test	At 3, 6, and 9 months.	- Success Criteria: More than a 10% increase over the baseline.
pulmonary function test	At 3, 6, and 9 months.	- Success Criteria: Increase in FVC, FEV1, or DLCO by more than 10% at the time of registration.
system compliance	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.

Trial Locations

Locations (1)

Division of Pulmonary and Critical Care Medicine; 🇰🇷 Seoul, Korea, Republic of