National Mobile Asthma Management System-E Project
1 other identifier
interventional
870
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable asthma
Started Mar 2017
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
March 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 4, 2019
June 1, 2019
2.2 years
August 8, 2016
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of good adherence at the 6th month
patients will fill out the MARS-A questionnaire on their own，and the MARS-A Scores will be calculated to show their adherence of medication. Good adherence: MARS-A score\>=4.5
6 months
Secondary Outcomes (10)
Forced expiratory volume in one second（FEV1）
1 year
Forced vital capacity(FVC)
1 year
Peak expiratory flow(PEF)
1 year
Emergency visits
1 year
Hospitalization
1 year
- +5 more secondary outcomes
Study Arms (2)
mobile management
EXPERIMENTALuse mobile management to improve asthma control
Traditional management
OTHERuse Traditional management to improve asthma control
Interventions
Patients in this group use a smartphone app in their asthma self-management.
Patients in this group use a printed asthma diary in their asthma self-management.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unable to communicate properly because of visual impairment, hearing impairment and language barrier, or with mental illness or psychological problems;
- Have a history of tracheal intubation or mechanical ventilation as a result of acute asthma attack;
- 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.
- Women with pregnancy, or planned pregnancy within one year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100000, China
Related Publications (1)
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.
PMID: 34983109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
August 8, 2016
First Posted
September 28, 2016
Study Start
March 25, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
June 4, 2019
Record last verified: 2019-06