Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)

Asthma Clinical Trial

Official title:

Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05972668
• Other study ID #: TH-IRB-0016-0038
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2023
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Smartphone Apps
The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Ministry of Health and Welfare	Taipei City	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan	Taipei Hospital, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	All participants were assessed for the total serum IgE (kU/I) change from blood assessment	The researcher and physician record and evaluate the data	3 and 6 months evaluation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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