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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Behavioral: Immediate application of the Smart Homespital system; Behavioral: Delayed application of the Smart Homespital system after 3 months

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mindong Sung, PhD; Phone Number: 010-6554-0827; Email: mdsung@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Division of Pulmonary and Critical Care Medicine
    • Contact: Mindong Sung, PhD; Phone Number: 010-6554-0827; Email: mdsung@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After applying the Smart Homespital system(12weaks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Survey every 2 weeks during the 12-week Homespital system application, then at 3, 6, and 9 months after the start of the study.
Service satisfaction evaluation	CSQ-8: After 12 weeks of applying the Smart Homespital system.; Success Criteria: Achieving 4 points or more.	After 12 weeks of applying the Smart Homespital system.
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.	Measured after the study ends (9 months later).
cost assessment	- Criteria: Comparison of average hospital respiratory rehabilitation treatment costs with the Smart Homespital program's costs.	After study ends (9 months later)
6 minute walking test	- Success Criteria: More than a 10% increase over the baseline.	At 3, 6, and 9 months.
pulmonary function test	- Success Criteria: Increase in FVC, FEV1, or DLCO by more than 10% at the time of registration.	At 3, 6, and 9 months.
system compliance	-Criteria: Maintaining a minimum of 5,000 steps/day during the 12-week period of applying the Homespital system.	During the 12-week period of applying the Homespital system.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): May 2, 2026
• Study Completion (Estimated): May 2, 2026

Study Registration Dates

• First Submitted: September 8, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 4-2024-0300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No