AsthmaNCT04808089
The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients
A study testing Health Lung App. of mobile phone+ezOxygen mobile spirometry in people with Asthma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Health Lung App. of mobile phone+ezOxygen mobile spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Apr 2021to 31 Jul 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 65 years old.
- Regular prescription of inhaled corticosteroid-containing medications at least 6 months.
- The asthma control is well but not in total control: ACT 20~24, but not to full score 25.
Who cannot join
- Patients were excluded if they do not have internet-connecting smart phone.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 33305
Ting-Yu Lin, MD, 886-3-3281200 ext. 8157, yuebaoyuebao@yahoo.com.tw
Ting-Yu Lin, MD
About this study
Official title: The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients to Achieve Optimal Asthma Control
The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.
Read the detailed description
Asthma is a chronic inflammatory disease. Despite we have academic treatment guidelines, and the asthma treatment develops persistently, many asthma patients do not have well control.
Asthma Control Test (ACT) is a patient self-administered tool for identifying those with poorly controlled asthma. ACT includes 5 items on 5-point scale, with 4-week recall on symptoms and daily functioning. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
In addition to correct diagnosis and prescription by physicians, achieving asthma well control depend on the patient's ability of self- management.
The self-management of asthma patients includes monitor of symptoms, monitor of peak expiratory flow, compliance of inhaler and avoiding the asthma triggers.
Portable digital tools may be the possible solution for home monitor of asthma patients. Through the application of mobile phone and hand-held mobile spirometry, asthma patients can monitor their symptoms and lung function at home outside of hospital.(5-7)。
"Health Lung" (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch).
Therefore, the functions of this App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality. The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".
However, how the patients are willing to use digital tools at home and what is the real impact on the current hospital-based asthma care need to be validated.
The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.
- Conditions
- Asthma
- Being tested
- Health Lung App. of mobile phone+ezOxygen mobile spirometry, Usual care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Lung App. of mobile phone+ezOxygen mobile spirometryOther
Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital.
The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".
Usual careOther
The research assistant assess/ teach inhaler technique, offering advice on adherence, delivering patient self-management asthma action plan and education the meaning of asthma control accessed by ACT.
| Study group | Role | What they receive |
|---|---|---|
| Health Lung App. +ezOxygen | Experimental | Health Lung" App. (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch).
The functions of Health Lung App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality
Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital.
he physicians in charge will get the information about control status score by ACT, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung". Receives: Other: Health Lung App. of mobile phone+ezOxygen mobile spirometry |
| Usual care | Active comparator | The research assistant assess/ teach inhaler technique, offering the asthma education as the regular clinical service. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
The improvement of asthma control evaluated by Asthma Control Test (ACT). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: 3 months
Secondary outcomes (2)
The compliance of controller
The adherence of asthma inhaler drugs will be evaluated by the questionnaire about inhaler compliance.
According to your memory, how often did you forget to follow the doctor's order to use the inhaler(s) in the past 4 weeks?
1.Almost every day; 2. No more than 7 days; 3. No more than 14 days; 4. More than 15 days
Measured: 3 months
The satisfaction of digital tools in study group
The subjects in study arm will be asked about how they satisfy the functions of "Health lung" App. and ezOxygen spirometry via 100-mm length visual analogue scale. 0: the most dissatisfaction/unhelpful to 100 mm: the most satisfaction/helpful
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start2 Apr 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Jul 2022 (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.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Prospective randomized control trial
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Yu Lin, Chang Gung Memorial Hospital
- Investigators
- Ting-Yu Lin, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808089
- Sponsor's protocol ID
- 202100251B0
- Status last verified
- Mar 2021
- First submitted
- 18 Mar 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients to Achieve Optimal Asthma Control
- ClinicalTrials.gov ID
- NCT04808089
- Acronym / sponsor ID
- 202100251B0
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 19 Mar 2021 (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 aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.
Detailed description
Asthma is a chronic inflammatory disease. Despite we have academic treatment guidelines, and the asthma treatment develops persistently, many asthma patients do not have well control.
Asthma Control Test (ACT) is a patient self-administered tool for identifying those with poorly controlled asthma. ACT includes 5 items on 5-point scale, with 4-week recall on symptoms and daily functioning. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
In addition to correct diagnosis and prescription by physicians, achieving asthma well control depend on the patient's ability of self- management.
The self-management of asthma patients includes monitor of symptoms, monitor of peak expiratory flow, compliance of inhaler and avoiding the asthma triggers.
Portable digital tools may be the possible solution for home monitor of asthma patients. Through the application of mobile phone and hand-held mobile spirometry, asthma patients can monitor their symptoms and lung function at home outside of hospital.(5-7)。
"Health Lung" (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch).
Therefore, the functions of this App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality. The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".
However, how the patients are willing to use digital tools at home and what is the real impact on the current hospital-based asthma care need to be validated.
The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Health Lung App. +ezOxygen | Experimental | Other: Health Lung App. of mobile phone+ezOxygen mobile spirometryHealth Lung" App. (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch). The functions of Health Lung App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital. he physicians in charge will get the information about control status score by ACT, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung". |
| Usual care | Active comparator | Other: Usual careThe research assistant assess/ teach inhaler technique, offering the asthma education as the regular clinical service. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 to 65 years old.
- Regular prescription of inhaled corticosteroid-containing medications at least 6 months.
- The asthma control is well but not in total control: ACT 20~24, but not to full score 25.
Key exclusion criteria (1 listed)
- Patients were excluded if they do not have internet-connecting smart phone.
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 |
|---|---|---|
| Health Lung App. of mobile phone+ezOxygen mobile spirometrySubjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital. The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung". | Other | Health Lung App. +ezOxygen |
| Usual careThe research assistant assess/ teach inhaler technique, offering advice on adherence, delivering patient self-management asthma action plan and education the meaning of asthma control accessed by ACT. | Other | Usual care |
Primary outcome
Asthma control
Time frame: 3 months
The improvement of asthma control evaluated by Asthma Control Test (ACT). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
2 secondary outcomes
The compliance of controller
Time frame: 3 months
The satisfaction of digital tools in study group
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
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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.
Ting-Yu Lin, M.D. principal investigator
Chang Gung Memorial 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 Health Lung App. of mobile phone+ezOxygen mobile spirometry in people with Asthma, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 30 Jul 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Yu Lin (886-3-3281200 ext. 8468, yuebaoyuebao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: 3 months). 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 30 Jul 2021.