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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Smartphone Apps

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei
    • Taipei City, Taipei, Taiwan, 242
      • Taipei Hospital, Ministry of Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention Group; Intervention group needs to download the smartphone apps and follow research protocol	Device: Smartphone Apps; The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology, Taiwan
• Collaborators: Taipei Hospital, Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: hospital admission; asthma control; emergency room visit; Smartphone selft-care system; medical cost
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: TH-IRB-0016-0038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We don not plan to share individual participant data (IPD)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No