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

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ClinicalTrials.gov Identifier: NCT03327363
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Collaborators:
Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center
Information provided by (Responsible Party):
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').


Condition or disease Intervention/treatment Phase
Asthma Device: Feedback using ICT based monitoring system Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a prospective, randomized controlled, multicenter study
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 30, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. asthma control score [ Time Frame: up to 24 weeks after enrollment ]
    Asthma control status will be checked using asthma control questionnaire (ACQ),

  2. exacerbation rate [ Time Frame: up to 24 weeks after enrollment ]
    exacerbation was defined as symptom score, and lung function

  3. change of FEV1 [ Time Frame: up to 24 weeks after enrollment ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327363


Contacts
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Contact: young-eun choi -82-53-640-6516 duddms1232@ymc.yu.ac.kr
Contact: Song-A choi +82-53-640-6516 sav1121@ymc.yu.ac.kr

Locations
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Korea, Republic of
Yeungnam University Hospital Recruiting
Daegu, Korea, Republic of, 705-802
Contact: Young-eun Choi    +82-53-640-6516    duddms1232@ymc.yu.ac.kr   
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         
Sponsors and Collaborators
Yeungnam University Hospital
Ministry of Trade, Industry & Energy, Republic of Korea
Korea Evaluation Institute of Industrial Technology
Daegu Metropolitan City, Korea
ICT Clinical Trial Coordination Center
Investigators
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Study Chair: Hunn Jung Jin, MD Yeungnam University Hospital

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Responsible Party: Yeungnam University Hospital
ClinicalTrials.gov Identifier: NCT03327363     History of Changes
Other Study ID Numbers: ICT-RTM-P06 Asthma
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yeungnam University Hospital:
ICT based clinical trial,
eCRF
electronic -institutional review board (eIRB),
Centralized monitoring
contract research organization (CRO)

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases