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CompletedNCT05972668Updated Aug 2, 2023

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

An interventional study of Smartphone Apps in Asthma, sponsored by Ministry of Science and Technology, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
3 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Smartphone selft-care system
  • asthma control
  • medical cost
  • emergency room visit
  • hospital admission
03

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    Intervention Group

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

    Device: Smartphone Apps

  • No intervention
    Control group

Interventions

  • DeviceSmartphone Apps

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 and 6 months evaluation

  2. 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

    Time frame: 3 and 6 months evaluation

  3. All participants were assessed for the change of Quality of life using MiniPAQLQ

    Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire

    Time frame: 3 and 6 months evaluation

  4. 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

    Time frame: 3 and 6 months evaluation

  5. All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry

    The physician evaluate PEF change at Taipei Hospital for both group

    Time frame: 3 and 6 months

  6. 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

    Time frame: 3 and 6 months

Secondary outcomes

  1. 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

    Time frame: Baseline

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

    The researcher and physician record and evaluate the data

    Time frame: 3 and 6 months evaluation

  3. 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

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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

    Time frame: Baseline

  6. 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

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. 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

    Time frame: Baseline

06

Study locations

1 site
  • Taipei Hospital, Ministry of Health and Welfare
    Taipei City, Taipei 242, Taiwan
07

References and documents

Study documents

  • Statistical analysis plan · Feb 17, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — We don not plan to share individual participant data (IPD)

08

Registry details

Key details

Study ID
NCT05972668
Lead sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taipei Hospital, Ministry of Health and Welfare
Responsible party
I-Jen, Wang (Clinical Professor, Taipei Hospital, Ministry of Health and Welfare) — Principal investigator
First posted
Aug 2, 2023
Start date
Feb 1, 2017
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021
Last update
Aug 2, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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