Clinical trial NCT03327363: Information and Communication Technology (ICT)- Based Centralized Monitoring System of Asthma Control
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: ICT based clinical trial,
eCRF
electronic -institutional review board (eIRB),
Centralized monitoring
contract research organization (CRO)
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy, Republic of Korea
name: Korea Evaluation Institute of Industrial Technology
name: Daegu Metropolitan City, Korea
name: ICT Clinical Trial Coordination Center
First posted: 2017-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a prospective, randomized controlled, multicenter study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: asthma control score
timeFrame: up to 24 weeks after enrollment
measure: exacerbation rate
timeFrame: up to 24 weeks after enrollment
measure: change of FEV1
timeFrame: up to 24 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
affiliation: Yeungnam University Hospital
name: Hunn Jung Jin, MD
role: STUDY_CHAIR
References: