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

October 26, 2017 updated by: Yeungnam University Hospital

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

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').

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-802
        • Recruiting
        • Yeungnam University Hospital
        • Contact:
        • Principal Investigator:
          • HyunJung Jin, MD
        • Sub-Investigator:
          • Jun-Hong Ahn, MD
        • Sub-Investigator:
          • Ji-Sun Kim, MD
        • Principal Investigator:
          • Su-Jung Kim, MD
        • Principal Investigator:
          • Sung ken Yu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Placebo Comparator: control group
Use standard asthma treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeungnam University Hospital

Collaborators

Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center

Investigators

  • Study Chair: Hunn Jung Jin, MD, Yeungnam University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2017

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICT-RTM-P06 Asthma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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