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

NCT05972668 | Completed DMC

• 1 other identifier: TH-IRB-0016-0038
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Smartphone selft-care system; asthma control; medical cost; emergency room visit; hospital admission

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• All participants were assessed for their age in the baseline using data of birthday information

  Baseline

• All participants were assessed for the total serum IgE (kU/I) change from blood assessment

  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

  Baseline

• All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance

  Baseline

• All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Intervention group needs to download the smartphone apps and follow research protocol

Device: Smartphone Apps

Control group

NO INTERVENTION

Interventions

Smartphone Apps DEVICE

The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits

Intervention Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Science and Technology, Taiwan: lead
• Taipei Hospital, Ministry of Health and Welfare: collaborator

Study Sites (1)

Taipei Hospital, Ministry of Health and Welfare

Taipei City, Taipei, 242, Taiwan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 2, 2023
• Study Start: February 1, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)