Asthma
Conditions
Keywords
ICT based clinical trial,, eCRF, electronic -institutional review board (eIRB),, Centralized monitoring, contract research organization (CRO)
Brief summary
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
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.
Interventions
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.
Sponsors
Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center
Yeungnam University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
a prospective, randomized controlled, multicenter study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| asthma control score | up to 24 weeks after enrollment | Asthma control status will be checked using asthma control questionnaire (ACQ), |
| exacerbation rate | up to 24 weeks after enrollment | exacerbation was defined as symptom score, and lung function |
| change of FEV1 | up to 24 weeks after enrollment | — |
Countries
South Korea
Contacts
Primary Contactyoung-eun choi
Backup ContactSong-A choi
Outcome results
None listed