Clinical trial NCT05972668: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Smartphone selft-care system
asthma control
medical cost
emergency room visit
hospital admission
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Taipei Hospital, Ministry of Health and Welfare
First posted: 2023-08-02
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: 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
timeFrame: 3 and 6 months evaluation
measure: All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated
timeFrame: 3 and 6 months evaluation
measure: All participants were assessed for the change of Quality of life using MiniPAQLQ
timeFrame: 3 and 6 months evaluation
measure: All participants were assessed for the Asthma Control Test change using Paediatric Asthma Quality of Life Questionnaire (PAQLQ) questionnaire
timeFrame: 3 and 6 months evaluation
measure: All participants were assessed for the Peak Expiratory Flow (PEF) change using spirometry
timeFrame: 3 and 6 months
measure: All participants were assessed for the change of asthma cost using direct and indirect costs from national website
timeFrame: 3 and 6 months
Secondary outcomes:
measure: All participants were assessed for their age in the baseline using data of birthday information
timeFrame: Baseline
measure: All participants were assessed for the total serum IgE (kU/I) change from blood assessment
timeFrame: 3 and 6 months evaluation
measure: All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
measure: All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
measure: All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
measure: All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
measure: All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
measure: All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
state: Taipei
Study officials:
References: