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

Not Applicable

• Conditions: Asthma
• Interventions: Device: Feedback using ICT based monitoring system

• Registration Number: NCT03327363
• Lead Sponsor: Yeungnam University Hospital

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.

Study Timeline

• Study Start: 2017-04-30
• Study First Submitted: 2017-05-30
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-26
• Last Update Submitted: 2017-10-26
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICT base monitoring group	Feedback using ICT based monitoring system	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	Feedback using ICT based monitoring system	Use standard asthma treatment

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yeungnam University Hospital; 🇰🇷 Daegu, Korea, Republic of