NCT03327363

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').

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

May 30, 2017

Last Update Submit

October 26, 2017

Conditions

Asthma

Keywords

ICT based clinical trial,eCRFelectronic -institutional review board (eIRB),Centralized monitoringcontract research organization (CRO)

Outcome Measures

Primary Outcomes (3)

  • asthma control score

    Asthma control status will be checked using asthma control questionnaire (ACQ),

    up to 24 weeks after enrollment

  • exacerbation rate

    exacerbation was defined as symptom score, and lung function

    up to 24 weeks after enrollment

  • change of FEV1

    up to 24 weeks after enrollment

Study Arms (2)

ICT base monitoring group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

Use standard asthma treatment

Device: Feedback using ICT based monitoring system

Interventions

Feedback using ICT based monitoring systemDEVICE

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.

ICT base monitoring groupcontrol group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with plan of administration or operation within study periods
  • Unstable heart disease and psychical disorder
  • refuse the monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, 705-802, South Korea

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Hunn Jung Jin, MD

    Yeungnam University Hospital

    STUDY CHAIR

Central Study Contacts

young-eun choi

CONTACT

-82-53-640-6516duddms1232@ymc.yu.ac.kr

Song-A choi

CONTACT

+82-53-640-6516sav1121@ymc.yu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: a prospective, randomized controlled, multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2017

First Posted

October 31, 2017

Study Start

April 30, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)