Evaluation of the Effectiveness, Safety, and Cost of a Smart Hospital System for Patients With Chronic Obstructive Pulmonary Disease

NCT06601777 | Recruiting

• 1 other identifier: 4-2024-0299
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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).

• cost assessment

  After study ends (9 months later)

• 6 minute walking test

  At 3, 6, and 9 months.

Study Arms (2)

intervention group

EXPERIMENTAL

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

attention-waitlist control group

EXPERIMENTAL

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

Interventions

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.

intervention group

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.

attention-waitlist control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with COPD who meet the following pulmonary function test results:
• Pre FEV1 \< 80% \*\*or\*\*
• Pre FVC \< 80% \*\*or\*\*
• DLCO \< 60%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2024
• First Posted: September 19, 2024
• Study Start: September 5, 2024
• Primary Completion: May 2, 2026
• Study Completion: May 2, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)