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| Name | Class |
|---|---|
| Taipei Hospital, Ministry of Health and Welfare | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Intervention group needs to download the smartphone apps and follow research protocol |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone Apps | Device | The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| All participants were assessed for the total serum IgE (kU/I) change from blood assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Hospital, Ministry of Health and Welfare | Taipei City | Taipei | 242 | Taiwan |
We don not plan to share individual participant data (IPD)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2017 | Jul 15, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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The researcher and physician record and evaluate the data |
| 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 | 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 | 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 | 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 | 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 | 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 | Baseline |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |