Information and Communication Technology (ICT)- Based Centralized Monitoring System of Asthma Control

Study Overview
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Brief Summary
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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').

Detailed Description
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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.

Official Title
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The Clinical Efficacy and Stability of Information and Communication Technology (ICT)- Based Centralized Monitoring System of Asthma Control Monitoring in Asthma Patients: a Prospective, Randomized Controlled, Multicenter Study

Conditions
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Asthma

Intervention / Treatment
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* Device: Feedback using ICT based monitoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asthma patients diagnosed by doctors Current treatment with Inhaled corticosteroid or leukotriene receptor antagonist able to give written informed consent prior to participation in the study Exclusion Criteria: Subjects with plan of administration or operation within study periods Unstable heart disease and psychical disorder refuse the monitoring

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a prospective, randomized controlled, multicenter study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICT base monitoring group<br>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 | Device: Feedback using ICT based monitoring system<br>* 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.<br>|
| Placebo Comparator: control group<br>Use standard asthma treatment | Device: Feedback using ICT based monitoring system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICT based clinical trial,, eCRF, electronic -institutional review board (eIRB),, Centralized monitoring, contract research organization (CRO)