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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Smartphone Apps
Sponsored by
Ministry of Science and Technology, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Smartphone selft-care system, asthma control, medical cost, emergency room visit, hospital admission

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Hospital, Ministry of Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control group

Arm Description

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

Outcomes

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
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
The physician evaluate ACT change at Taipei Hospital for both group
All participants were assessed for the change of Quality of life using MiniPAQLQ
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
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
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
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
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
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
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
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
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
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
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
The researcher and physician record and evaluate the data

Full Information

First Posted
July 7, 2023
Last Updated
July 24, 2023
Sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taipei Hospital, Ministry of Health and Welfare
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1. Study Identification

Unique Protocol Identification Number
NCT05972668
Brief Title
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
Official Title
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taipei Hospital, Ministry of Health and Welfare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Smartphone selft-care system, asthma control, medical cost, emergency room visit, hospital admission

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group needs to download the smartphone apps and follow research protocol
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Smartphone Apps
Intervention Description
The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits
Primary Outcome Measure Information:
Title
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
Description
The physician diagnoses asthma change at Taipei Hospital
Time Frame
3 and 6 months evaluation
Title
All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated
Description
The physician evaluate ACT change at Taipei Hospital for both group
Time Frame
3 and 6 months evaluation
Title
All participants were assessed for the change of Quality of life using MiniPAQLQ
Description
Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire
Time Frame
3 and 6 months evaluation
Title
All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire
Description
The physician evaluate PASS score change at Taipei Hospital for both group
Time Frame
3 and 6 months evaluation
Title
All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry
Description
The physician evaluate PEF change at Taipei Hospital for both group
Time Frame
3 and 6 months
Title
All participants were assessed for the change of asthma cost using direct and indirect costs from national website
Description
Researchers access the data from National Health Insurance database
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
All participants were assessed for their age in the baseline using data of birthday information
Description
Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital
Time Frame
Baseline
Title
All participants were assessed for the total serum IgE (kU/I) change from blood assessment
Description
The researcher and physician record and evaluate the data
Time Frame
3 and 6 months evaluation
Title
All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline
Title
All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline
Title
All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline
Title
All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline
Title
All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline
Title
All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance
Description
The researcher and physician record and evaluate the data
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Taipei Hospital, Ministry of Health and Welfare
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
242
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We don not plan to share individual participant data (IPD)

Learn more about this trial

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

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