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| Name | Class |
|---|---|
| Ministry of Trade, Industry & Energy, Republic of Korea | OTHER_GOV |
| Korea Evaluation Institute of Industrial Technology | OTHER |
| Daegu Metropolitan City, Korea | OTHER_GOV |
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The aims of this study is to evaluation of the clinical efficacy and stability of Information and Communication Technology (ICT)- based centralized monitoring system of asthma control monitoring in asthma patients. We planed to enroll 100 asthma patients (50 subjects using ICT systems, 50 controls). We will monitor the asthma control status, lung function, exacerbation rate and stability of ICT systems.
This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization').
This study has a multi- center, open- label, prospective and randomized clinical trial design. One hundred asthma patients who fill out the informed consent form are registered and randomized 1:1 into the ICT-based centralized clinical trial monitoring group (n=50) or the ambulatory follow-up group (n=50). The planned follow-up duration is 6 months. he ICT-based centralized clinical trial monitoring group is given home based spirometry and connecting system (gateway) equipped with personal identification system. Fingerprint registration is required in advance, so that it would be used for authentication before each use of spirometry. Symptom score and lung functions (FEV1, PEFR) obtained from gateway is saved, monitored, and sent out via a home-monitoring system. In the ICT-based centralized clinical trial monitoring group, feedback is sent to both patients and medical staff in the form of texts if there is a worsening of symptoms score and/or lung function.
Subjects are to make office visits after randomization at 4, (8), 12, (16, 20), and 24 weeks. (ICT group will not visit at the schedules in the brackets) Each visit requires measurement of Questionnaire (ACQ) lung functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICT base monitoring group | Experimental | In the ICT-based centralized monitoring group, both subjects and medical staff receive feedback regarding decreased lung function and exacerbation in asthma symptoms in the form of text messages |
|
| control group | Placebo Comparator | Use standard asthma treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback using ICT based monitoring system | Device | In experimental group, the subjects the check their lung function using self FEV1 monitoring device (microlife PF-200). They send the information to central monitoring system(EDC systems). In case of decreased FEV1 compared with own average FEV1, the ICT based monitoring system send the feedback message to the subject and medical staffs. |
| Measure | Description | Time Frame |
|---|---|---|
| asthma control score | Asthma control status will be checked using asthma control questionnaire (ACQ), | up to 24 weeks after enrollment |
| exacerbation rate | exacerbation was defined as symptom score, and lung function | up to 24 weeks after enrollment |
| change of FEV1 | up to 24 weeks after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| young-eun choi | Contact | -82-53-640-6516 | duddms1232@ymc.yu.ac.kr | |
| Song-A choi | Contact | +82-53-640-6516 | sav1121@ymc.yu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Hunn Jung Jin, MD | Yeungnam University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Hospital | Recruiting | Daegu | 705-802 | South Korea |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ICT Clinical Trial Coordination Center |
| OTHER |
a prospective, randomized controlled, multicenter study
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |