BRONCHIAL ASTHMANCT01918293
Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult
A study testing SMART ARM in people with BRONCHIAL ASTHMA, run by Inje University at 1 site in South Korea.
Trial summary
Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- BRONCHIAL ASTHMA
- What is being tested?
- SMART ARM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Oct 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- using smartphone
- alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test
Who cannot join
- COPD
- active pulmonary TUBERCULOSIS
- Acute exacerbation within 4weeks
- severe psychological disorder
- severe systemic disease; severe LC, ESRD ...
- MALIGNANCY
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma) in Adult
Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.
- Conditions
- BRONCHIAL ASTHMA
- Being tested
- SMART ARM
- Keywords
- ASTHMA, SMARTPHONE APPLICATION
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART ARMDevice
Also called SMART-Asthma
The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.
| Study group | Role | What they receive |
|---|---|---|
| SMART arm | Experimental | Using smartphone application for control of asthma Receives: Device: SMART ARM |
| conventional arm | No intervention | non-using smartphone application for control asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of smartphone application for asthma control test (ACT)and quality of life
Using ACT and ALQL score (QoL), we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group
Measured: at least 2 times a week
Secondary outcomes (2)
FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)
Using spirometer to check the variation of FEV1,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group
Measured: at least 1 time a month
Acute exacerbation of bronchial asthma
Using medical record and questionaire of acute exacerbation,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group
Measured: at least 1 time a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRONCHIAL 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jongha Park, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918293
- Sponsor's protocol ID
- SMART-ASTHMA (ADULT)
- Status last verified
- Nov 2013
- First submitted
- 6 Aug 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma) in Adult
- ClinicalTrials.gov ID
- NCT01918293
- Acronym / sponsor ID
- SMART-ASTHMA (ADULT)
- Conditions
- BRONCHIAL ASTHMA
- Keywords
- ASTHMA, SMARTPHONE APPLICATION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Aug 2013 (estimated)
- 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.
Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART arm | Experimental | Device: SMART ARMUsing smartphone application for control of asthma |
| conventional arm | No intervention | –non-using smartphone application for control asthma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- using smartphone
- alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test
Key exclusion criteria (6 listed)
- COPD
- active pulmonary TUBERCULOSIS
- Acute exacerbation within 4weeks
- severe psychological disorder
- severe systemic disease; severe LC, ESRD ...
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 |
|---|---|---|
| SMART ARMAlso: SMART-AsthmaThe smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1. | Device | SMART arm |
Primary outcome
The efficacy of smartphone application for asthma control test (ACT)and quality of life
Time frame: at least 2 times a week
Using ACT and ALQL score (QoL), we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group
2 secondary outcomes
FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)
Time frame: at least 1 time a month
Acute exacerbation of bronchial asthma
Time frame: at least 1 time a week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Related trials for BRONCHIAL ASTHMA
RecruitingPhase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
Active, not recruiting
Nasal Immune Challenge Study
Innate Inflammatory Response, Asthma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART ARM in people with BRONCHIAL ASTHMA, run by Inje University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Nov 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of smartphone application for asthma control test (ACT)and quality of life (time frame: at least 2 times a week). 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 27 Nov 2013.