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

Sponsor

Ministry of Science and Technology, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT05972668

Collaborator

Taipei Hospital, Ministry of Health and Welfare (Other)

140

Enrollment

Location

Arms

51.9

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: Smartphone Apps	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 1, 2017

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control group

Arm

Intervention/Treatment

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

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

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
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 Quality of life using MiniPAQLQ [3 and 6 months evaluation]
Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
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 asthma cost using direct and indirect costs from national website [3 and 6 months]
Researchers access the data from National Health Insurance database

Secondary Outcome Measures

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 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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.