AsthmaNCT05972668
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
A study testing Smartphone Apps in people with Asthma, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to investigate whether a smartphone app based on the Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Smartphone Apps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2017to 1 Jun 2021
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged between 3 and 18 years;
- who had access to the smartphone app;
- with asthma treatment steps 2-4, requiring regular treatment with controller medication (for at least 6 months over the past year) according to the GINA guidelines;
- who had at least two clinic or emergency department visits related to asthma in the previous year.
Who cannot join
- Children who had comorbidities, or other major medical problems, and who did not have a smartphone or whose caregivers did not have a smartphone were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Ministry of Health and Welfare
Taipei City, Taipei, 242
About this study
The goal of this clinical trial is to investigate whether a smartphone app based on the Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. The main question it to answer whether this app can improve asthma control, increase the quality of life, and decrease asthma-related costs.
Participants in the intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits, while the control group received reminder calls. Researchers will compare with the control group to see if the intervention receives more asthma control improvement.
- Conditions
- Asthma
- Being tested
- Smartphone Apps
- Keywords
- Smartphone selft-care system, asthma control, medical cost, emergency room visit, hospital admission
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone AppsDevice
The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group needs to download the smartphone apps and follow research protocol Receives: Device: Smartphone Apps |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline
The physician diagnoses asthma change at Taipei Hospital
Measured: 3 and 6 months evaluation
All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated
The physician evaluate ACT change at Taipei Hospital for both group
Measured: 3 and 6 months evaluation
All participants were assessed for the change of Quality of life using MiniPAQLQ
Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
Measured: 3 and 6 months evaluation
All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire
The physician evaluate PASS score change at Taipei Hospital for both group
Measured: 3 and 6 months evaluation
All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry
The physician evaluate PEF change at Taipei Hospital for both group
Measured: 3 and 6 months
All participants were assessed for the change of asthma cost using direct and indirect costs from national website
Researchers access the data from National Health Insurance database
Measured: 3 and 6 months
Secondary outcomes (8)
All participants were assessed for their age in the baseline using data of birthday information
Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital
Measured: Baseline
All participants were assessed for the total serum IgE (kU/I) change from blood assessment
The researcher and physician record and evaluate the data
Measured: 3 and 6 months evaluation
All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance
The researcher and physician record and evaluate the data
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Feb 2017
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Collaborators
- Taipei Hospital, Ministry of Health and Welfare
- Responsible party
- Principal investigator, I-Jen, Wang, Taipei Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972668
- Sponsor's protocol ID
- TH-IRB-0016-0038
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don not plan to share individual participant data (IPD)
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
- ClinicalTrials.gov ID
- NCT05972668
- Acronym / sponsor ID
- TH-IRB-0016-0038
- Conditions
- Asthma
- Keywords
- Smartphone selft-care system, asthma control, medical cost, emergency room visit, hospital admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Collaborators
- Taipei Hospital, Ministry of Health and Welfare
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 2 Aug 2023 (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 goal of this clinical trial is to investigate whether a smartphone app based on the Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of life, and decrease asthma-related costs in children. The main question it to answer whether this app can improve asthma control, increase the quality of life, and decrease asthma-related costs.
Participants in the intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits, while the control group received reminder calls. Researchers will compare with the control group to see if the intervention receives more asthma control improvement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Smartphone AppsIntervention group needs to download the smartphone apps and follow research protocol |
| Control group | No intervention | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged between 3 and 18 years;
- who had access to the smartphone app;
- with asthma treatment steps 2-4, requiring regular treatment with controller medication (for at least 6 months over the past year) according to the GINA guidelines;
- who had at least two clinic or emergency department visits related to asthma in the previous year.
Key exclusion criteria (1 listed)
- Children who had comorbidities, or other major medical problems, and who did not have a smartphone or whose caregivers did not have a smartphone were excluded from the study.
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 |
|---|---|---|
| Smartphone AppsThe intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits | Device | Intervention Group |
Primary outcome
Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline
Time frame: 3 and 6 months evaluation
The physician diagnoses asthma change at Taipei Hospital
All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated
Time frame: 3 and 6 months evaluation
The physician evaluate ACT change at Taipei Hospital for both group
All participants were assessed for the change of Quality of life using MiniPAQLQ
Time frame: 3 and 6 months evaluation
Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire
Time frame: 3 and 6 months evaluation
The physician evaluate PASS score change at Taipei Hospital for both group
All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry
Time frame: 3 and 6 months
The physician evaluate PEF change at Taipei Hospital for both group
All participants were assessed for the change of asthma cost using direct and indirect costs from national website
Time frame: 3 and 6 months
Researchers access the data from National Health Insurance database
8 secondary outcomes
All participants were assessed for their age in the baseline using data of birthday information
Time frame: Baseline
All participants were assessed for the total serum IgE (kU/I) change from blood assessment
Time frame: 3 and 6 months evaluation
All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance
Time frame: Baseline
All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance
Time frame: Baseline
All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance
Time frame: Baseline
All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance
Time frame: Baseline
All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance
Time frame: Baseline
All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance
Time frame: Baseline
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 2 Aug 2023.
- Individual participant dataSharing planned: No. We don not plan to share individual participant data (IPD)
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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.
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 Smartphone Apps in people with Asthma, run by Ministry of Science and Technology, Taiwan 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 4 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: finished, as of the sponsor's last update on 2 Aug 2023. 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?
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?
Number of participants both in intervention and control were assessed for the asthma severity change using Global Strategy for Asthma Management and Prevention (GINA) Guideline (time frame: 3 and 6 months evaluation). The study lists 6 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 2 Aug 2023.