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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Yonsei University
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Respiratory symptom questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Immediate application of the Smart Homespital system (Behavioral)
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.
Intervention: Delayed application of the Smart Homespital system after 3 months (Behavioral)
Outcomes
Primary Outcomes
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. 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 Outcomes
- cost assessment(After study ends (9 months later))
- 6 minute walking test(At 3, 6, and 9 months.)
- pulmonary function test(At 3, 6, and 9 months.)
- 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.)
- Service satisfaction evaluation(After 12 weeks of applying the Smart Homespital system.)
- safety(Measured after the study ends (9 months later).)
- system compliance(During the 12-week period of applying the Homespital system.)