AsthmaNCT03327363
Information and Communication Technology (ICT)- Based Centralized Monitoring System of Asthma Control
A study testing Feedback using ICT based monitoring system in people with Asthma, run by Yeungnam University Hospital at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Feedback using ICT based monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Apr 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects with plan of administration or operation within study periods
- Unstable heart disease and psychical disorder
- refuse the monitoring
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam University Hospital
Daegu, 705-802
Young-eun Choi, +82-53-640-6516, duddms1232@ymc.yu.ac.kr
HyunJung Jin, MD
About this study
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
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').
Read the 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.
- Conditions
- Asthma
- Being tested
- Feedback using ICT based monitoring system
- Keywords
- ICT based clinical trial,, eCRF, electronic -institutional review board (eIRB),, Centralized monitoring, contract research organization (CRO)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Feedback using ICT based monitoring system |
| control group | Placebo comparator | Use standard asthma treatment Receives: Device: Feedback using ICT based monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control score
Asthma control status will be checked using asthma control questionnaire (ACQ),
Measured: up to 24 weeks after enrollment
exacerbation rate
exacerbation was defined as symptom score, and lung function
Measured: up to 24 weeks after enrollment
change of FEV1
Measured: up to 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start30 Apr 2017
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, randomized controlled, multicenter study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Responsible party
- Sponsor
- Investigators
- Hunn Jung Jin, MD, Study chair, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327363
- Sponsor's protocol ID
- ICT-RTM-P06 Asthma
- Status last verified
- Oct 2017
- First submitted
- 30 May 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03327363
- Acronym / sponsor ID
- ICT-RTM-P06 Asthma
- Conditions
- Asthma
- Keywords
- ICT based clinical trial,, eCRF, electronic -institutional review board (eIRB),, Centralized monitoring, contract research organization (CRO)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea, Korea Evaluation Institute of Industrial Technology, Daegu Metropolitan City, Korea, ICT Clinical Trial Coordination Center
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective, randomized controlled, multicenter study
| Arm | Type | Receives |
|---|---|---|
| ICT base monitoring group | Experimental | Device: Feedback using ICT based monitoring systemIn 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 |
| control group | Placebo comparator | Device: Feedback using ICT based monitoring systemUse standard asthma treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects with plan of administration or operation within study periods
- Unstable heart disease and psychical disorder
- refuse the monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback using ICT based monitoring systemIn 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. | Device | ICT base monitoring group, control group |
Primary outcome
asthma control score
Time frame: up to 24 weeks after enrollment
Asthma control status will be checked using asthma control questionnaire (ACQ),
exacerbation rate
Time frame: up to 24 weeks after enrollment
exacerbation was defined as symptom score, and lung function
change of FEV1
Time frame: up to 24 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hunn Jung Jin, MD study chair
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback using ICT based monitoring system in people with Asthma, run by Yeungnam University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact young-eun choi (-82-53-640-6516, duddms1232@ymc.yu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
asthma control score (time frame: up to 24 weeks after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.