Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with Chronic Obstructive Pulmonary Disease to easily access and use biosignals generated using biosignal collection medical equipment at home.
Interventions
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.
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed