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

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: NCT05972668
• Lead Sponsor: Ministry of Science and Technology, Taiwan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated	3 and 6 months evaluation	The physician evaluate ACT 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	3 and 6 months	Researchers access the data from National Health Insurance database
All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire	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	3 and 6 months	The physician evaluate PEF change at Taipei Hospital for both group
All participants were assessed for the change of Quality of life using MiniPAQLQ	3 and 6 months evaluation	Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
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	3 and 6 months evaluation	The physician diagnoses asthma change at Taipei Hospital

Secondary Outcome Measures

Name	Time	Method
All participants were assessed for their age in the baseline using data of birthday information	Baseline	Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital
All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data
All participants were assessed for the total serum IgE (kU/I) change from blood assessment	3 and 6 months evaluation	The researcher and physician record and evaluate the data
All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data
All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data
All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data
All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data
All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance	Baseline	The researcher and physician record and evaluate the data

Trial Locations

Locations (1)

Taipei Hospital, Ministry of Health and Welfare; 🇨🇳 Taipei City, Taipei, Taiwan