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

NCT ID: NCT03327363

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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ICT based clinical trial, eCRF electronic -institutional review board (eIRB), Centralized monitoring contract research organization (CRO)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a prospective, randomized controlled, multicenter study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ICT base monitoring group

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

Group Type EXPERIMENTAL

Feedback using ICT based monitoring system

Intervention Type DEVICE

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.

control group

Use standard asthma treatment

Group Type PLACEBO_COMPARATOR

Feedback using ICT based monitoring system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Korea Evaluation Institute of Industrial Technology

OTHER

Sponsor Role collaborator

Daegu Metropolitan City, Korea

OTHER_GOV

Sponsor Role collaborator

ICT Clinical Trial Coordination Center

OTHER

Sponsor Role collaborator

Yeungnam University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hunn Jung Jin, MD

Role: STUDY_CHAIR

Yeungnam University Hospital

Locations

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Yeungnam University Hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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young-eun choi

Role: CONTACT

Phone: -82-53-640-6516

Email: [email protected]

Song-A choi

Role: CONTACT

Phone: +82-53-640-6516

Email: [email protected]

Facility Contacts

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Young-eun Choi

Role: primary

Other Identifiers

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ICT-RTM-P06 Asthma

Identifier Type: -

Identifier Source: org_study_id