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临床试验/NCT05972668
NCT05972668已完成不适用

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

Ministry of Science and Technology, Taiwan2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
2
主要终点
All participants were assessed for the Asthma Control Test (ACT) change using ACT questionnaire from quality metric incorporated

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 3 and 6 months evaluation

The physician evaluate ACT 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

时间窗: 3 and 6 months

Researchers access the data from National Health Insurance database

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

时间窗: 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

时间窗: 3 and 6 months

The physician evaluate PEF change at Taipei Hospital for both group

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

时间窗: 3 and 6 months evaluation

Physician and researchers evaluate the quality of life using MiniPAQLQ questionnaire

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

时间窗: 3 and 6 months evaluation

The physician diagnoses asthma change at Taipei Hospital

次要结局

  • All participants were assessed for their age in the baseline using data of birthday information(Baseline)
  • All participants were assessed for the comorbidities with allergic rhinitis using the health data record from Hospital and National Health Insurance(Baseline)
  • All participants were assessed for the total serum IgE (kU/I) change from blood assessment(3 and 6 months evaluation)
  • All participants were assessed for the comorbidities with atopic dermatitis using the health data record from Hospital and National Health Insurance(Baseline)
  • All participants were assessed for the family history of atopic disease using the health data record from Hospital and National Health Insurance(Baseline)
  • All participants were assessed for the systemic steroid dosage (prednisolone, mg), using the health data record from Hospital and National Health Insurance(Baseline)
  • All participants were assessed for the ICS Dosage (Seretide,mcg), using the health data record from Hospital and National Health Insurance(Baseline)
  • All participants were assessed for the Anti-leukotriene (montelukast, tab), using the health data record from Hospital and National Health Insurance(Baseline)

研究者

发起方
Ministry of Science and Technology, Taiwan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

I-Jen, Wang

Clinical Professor

Taipei Hospital, Ministry of Health and Welfare

研究点 (2)

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