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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327363
• Other study ID #: ICT-RTM-P06 Asthma
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: October 26, 2017
• Start date: April 30, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: October 2017
• Source: Yeungnam University Hospital
• Contact: young-eun choi
• Phone: -82-53-640-6516
• Email: duddms1232[@]ymc.yu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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').

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Feedback using ICT based monitoring system
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.

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu

Sponsors (5)

Lead Sponsor	Collaborator
Yeungnam University Hospital	Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center, Korea Evaluation Institute of Industrial Technology, Ministry of Trade, Industry and Energy, KOREA

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma control score	Asthma control status will be checked using asthma control questionnaire (ACQ),	up to 24 weeks after enrollment
Primary	exacerbation rate	exacerbation was defined as symptom score, and lung function	up to 24 weeks after enrollment
Primary	change of FEV1		up to 24 weeks after enrollment