Clinical trial NCT02917174: National Mobile Asthma Management System-E Project
Official title: National Mobile Asthma Management System-E Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
m-health
asthma control
self-management
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation, which is a common and frequently occurring disease in the world, and has resulted in a sustained increase of social and economic burden. However, several studies suggest, lots of asthma patients did not get their asthma controlled. The investigators study showed that in China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent years, application softwares of mobile-phones for asthma have gradually increased, studies suggested that application of these application softwares can make treatment more standard, reduce asthma attacks, help patients to control their asthma, improve adherence and these application softwares also show many other advantages. This study is a prospective, multi center, randomized, controlled study, aims to evaluate the efficacy of application softwares in asthma patients, provide a new tool to asthma management.


Eligibility criteria: Inclusion Criteria:

1.18 years of age or older, having been resided in the same city during the study; 2.A history of at least 3 months of diagnosed asthma based on the criteria established by GINA 2016; need to be on medication containing ICS or ICS/LABA 3.Asthma out patients with ACT scores﹤20 and MARS - A mean score \< 4.5 ; 4.Owning and Being able to use smart phone that the corresponding software can be successfully installed; 5.Subjects who are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Unable to communicate properly because of visual impairment, hearing impairment and language barrier, or with mental illness or psychological problems;
2. Have a history of tracheal intubation or mechanical ventilation as a result of acute asthma attack;
3. Have respiratory tract infection within the prior 4 weeks; history of thoracic surgery; with comorbidities such as other/structural lung diseases (COPD, bronchiectasis, lung cancer, et al); heart disease; kidney or autoimmunity disease; or other conditions that could potentially effect asthma control or asthma disease status by investigator's medical opinion.
4. Women with pregnancy, or planned pregnancy within one year.

Primary outcomes:
measure: Proportion of good adherence at the 6th month
timeFrame: 6 months
Secondary outcomes:
measure: Forced expiratory volume in one second（FEV1）
timeFrame: 1 year
measure: Forced vital capacity(FVC)
timeFrame: 1 year
measure: Peak expiratory flow(PEF)
timeFrame: 1 year
measure: Emergency visits
timeFrame: 1 year
measure: Hospitalization
timeFrame: 1 year
measure: Asthma Control Test（ACT）
timeFrame: 1 year
measure: Proportion of good adherence
timeFrame: 1 year
measure: Asthma Quality of Life Questionnaire(AQLQ)
timeFrame: 1 year
measure: Correct answer rate of the given asthma awareness questions
timeFrame: 1 year
measure: Fractional exhaled nitric oxide(FeNO)
timeFrame: 1year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
citation: Lin J, Wang W, Tang H, Huo J, Gu Y, Liu R, Chen P, Yuan Y, Yang X, Xu J, Sun D, Li N, Jiang S, Chen Y, Wang C, Yang L, Liu X, Yang D, Zhang W, Chen Z, Lin Q, Liu C, Zhou J, Zhou X, Hu C, Jiang P, Zhou W, Zhang J, Cai S, Qiu C, Huang M, Huang Y, Liu H; China Asthma Research Collaboration Network. Asthma Management Using the Mobile Asthma Evaluation and Management System in China. Allergy Asthma Immunol Res. 2022 Jan;14(1):85-98. doi: 10.4168/aair.2022.14.1.85.