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

NCT ID: NCT05972668

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2021-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Smartphone Apps

Intervention Type: DEVICE

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

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Smartphone Apps

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Hospital, Ministry of Health and Welfare

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

I-Jen, Wang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Hospital, Ministry of Health and Welfare

Taipei City, Taipei, Taiwan

Countries

Taiwan

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TH-IRB-0016-0038

Identifier Type: -

Identifier Source: org_study_id