Asthma Clinical Trial
Official title:
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
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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