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Completed

NCT Number: NCT05972668

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

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.

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Key information

Conditions

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

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Hospital, Ministry of Health and Welfare

Taipei City, Taipei, 242, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone Apps

Device

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

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

    Time frame: 3 and 6 months evaluation

    The physician diagnoses asthma change at Taipei Hospital

  2. All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated

    Time frame: 3 and 6 months evaluation

    The physician evaluate ACT change at Taipei Hospital for both group

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

    Time frame: 3 and 6 months evaluation

    Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire

  4. All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire

    Time frame: 3 and 6 months evaluation

    The physician evaluate PASS score change at Taipei Hospital for both group

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

    Time frame: 3 and 6 months

    The physician evaluate PEF change at Taipei Hospital for both group

  6. All participants were assessed for the change of asthma cost using direct and indirect costs from national website

    Time frame: 3 and 6 months

    Researchers access the data from National Health Insurance database

Secondary outcomes

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

    Time frame: Baseline

    Nurses and or researchers is responsible in filling the data from the patient admission in the Hospital

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

    Time frame: 3 and 6 months evaluation

    The researcher and physician record and evaluate the data

  3. All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance

    Time frame: Baseline

    The researcher and physician record and evaluate the data

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

    Time frame: Baseline

    The researcher and physician record and evaluate the data

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

    Time frame: Baseline

    The researcher and physician record and evaluate the data

  6. All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance

    Time frame: Baseline

    The researcher and physician record and evaluate the data

  7. All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance

    Time frame: Baseline

    The researcher and physician record and evaluate the data

  8. All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance

    Time frame: Baseline

    The researcher and physician record and evaluate the data

Sponsors and collaborators

Lead sponsor

Ministry of Science and Technology, Taiwan

Other Gov

Collaborators

  • Taipei Hospital, Ministry of Health and Welfare

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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