Interstitial Lung DiseaseNCT06601790
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
A study testing Immediate application of the Smart Homespital system and Delayed application of the Smart Homespital system after 3 months in people with Interstitial Lung Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Immediate application of the Smart Homespital system and Delayed application of the Smart Homespital system after 3 months
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with COPD who meet the following pulmonary function test results:
- Pre FEV1 < 80% or
- Pre FVC < 80% or
- DLCO < 60%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Pulmonary and Critical Care Medicine
Seoul, 03722
About this study
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.
- Conditions
- Interstitial Lung Disease
- Being tested
- Immediate application of the Smart Homespital system, Delayed application of the Smart Homespital system after 3 months
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate application of the Smart Homespital systemBehavioural
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.
Delayed application of the Smart Homespital system after 3 monthsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Delayed application of the Smart Homespital system after 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: After applying the Smart Homespital system(12weaks)
Secondary outcomes (7)
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
Measured: 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.
Measured: 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: 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.
Measured: After study ends (9 months later)
6 minute walking test
- Success Criteria: More than a 10% increase over the baseline.
Measured: 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.
Measured: 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.
Measured: During the 12-week period of applying the Homespital system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024
- Primary completion20 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601790
- Sponsor's protocol ID
- 4-2024-0300
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06601790
- Acronym / sponsor ID
- 4-2024-0300
- Conditions
- Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Immediate application of the Smart Homespital systemThe 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. |
| attention-waitlist control group | Experimental | Behavioral: Delayed application of the Smart Homespital system after 3 monthsThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pre FEV1 < 80% or
- Pre FVC < 80% or
- DLCO < 60%
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate application of the Smart Homespital systemThe 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. | Behavioural | intervention group |
| Delayed application of the Smart Homespital system after 3 monthsThe 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. | Behavioural | attention-waitlist control group |
Primary outcome
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
7 secondary outcomes
Depression Questionnaire
Time frame: 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
Time frame: After 12 weeks of applying the Smart Homespital system.
safety
Time frame: Measured after the study ends (9 months later).
cost assessment
Time frame: After study ends (9 months later)
6 minute walking test
Time frame: At 3, 6, and 9 months.
pulmonary function test
Time frame: At 3, 6, and 9 months.
system compliance
Time frame: During the 12-week period of applying the Homespital system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate application of the Smart Homespital system and Delayed application of the Smart Homespital system after 3 months in people with Interstitial Lung Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory symptom questionnaire (time frame: After applying the Smart Homespital system(12weaks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.