Back to resultsNational Mobile Asthma Management System-E Project
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mobile Asthma Management System
traditional Asthma Management System
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring asthma, m-health, asthma control, self-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:
- 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.
Sites / Locations
- China-Japan Friendship Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
mobile management
Traditional management
Arm Description
use mobile management to improve asthma control
use Traditional management to improve asthma control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Forced expiratory volume in one second（FEV1）
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of FEV1 will be calculated to show their pulmonary function.(The predicted value of FEV1 can be calculated when age,gender,height and weight are already known.)
Forced vital capacity(FVC)
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of FVC will be calculated to show their pulmonary function.
Peak expiratory flow(PEF)
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of PEF will be calculated to show their pulmonary function.
Emergency visits
patients will report their times of emergency visits to the researchers.
Hospitalization
patients will report their times of hospitalization to the researchers.
Asthma Control Test（ACT）
patients will fill out the ACT questionnaire on their own，and the ACT Scores of 25 is classified as well-controlled asthma，between 20 and 24 as not well-controlled，and less than 20 as poorly controlled asthma. ACT score is used to describe the proportion of people with different levels of asthma control.
Proportion of good adherence
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. Compare the proportion of good adherence change with time, time points: 1st month, 2nd month, 3rd month, 6th month, 12th month.
Asthma Quality of Life Questionnaire(AQLQ)
patients will fill out the AQLQ questionnaire on their own，and the AQLQ Scores will be calculated to show their quality of life.
Correct answer rate of the given asthma awareness questions
patients will answer 4 questions about asthma, correct answer rate will be calculated to show their awareness of asthma.
Fractional exhaled nitric oxide(FeNO)
patients will accomplish the fractional exhaled nitric oxide test，and the result of fractional exhaled nitric oxide related to airway inflammation.
Full Information
NCT ID
NCT02917174
First Posted
August 8, 2016
Last Updated
June 3, 2019
Sponsor
China-Japan Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02917174
Brief Title
National Mobile Asthma Management System-E Project
Official Title
National Mobile Asthma Management System-E Project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, m-health, asthma control, self-management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
870 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mobile management
Arm Type
Experimental
Arm Description
use mobile management to improve asthma control
Arm Title
Traditional management
Arm Type
Other
Arm Description
use Traditional management to improve asthma control
Intervention Type
Behavioral
Intervention Name(s)
Mobile Asthma Management System
Intervention Description
Patients in this group use a smartphone app in their asthma self-management.
Intervention Type
Behavioral
Intervention Name(s)
traditional Asthma Management System
Intervention Description
Patients in this group use a printed asthma diary in their asthma self-management.
Primary Outcome Measure Information:
Title
Proportion of good adherence at the 6th month
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Forced expiratory volume in one second（FEV1）
Description
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of FEV1 will be calculated to show their pulmonary function.(The predicted value of FEV1 can be calculated when age,gender,height and weight are already known.)
Time Frame
1 year
Title
Forced vital capacity(FVC)
Description
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of FVC will be calculated to show their pulmonary function.
Time Frame
1 year
Title
Peak expiratory flow(PEF)
Description
patients will accomplish the pulmonary function test，and the percentage of actual value to predicted value of PEF will be calculated to show their pulmonary function.
Time Frame
1 year
Title
Emergency visits
Description
patients will report their times of emergency visits to the researchers.
Time Frame
1 year
Title
Hospitalization
Description
patients will report their times of hospitalization to the researchers.
Time Frame
1 year
Title
Asthma Control Test（ACT）
Description
patients will fill out the ACT questionnaire on their own，and the ACT Scores of 25 is classified as well-controlled asthma，between 20 and 24 as not well-controlled，and less than 20 as poorly controlled asthma. ACT score is used to describe the proportion of people with different levels of asthma control.
Time Frame
1 year
Title
Proportion of good adherence
Description
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. Compare the proportion of good adherence change with time, time points: 1st month, 2nd month, 3rd month, 6th month, 12th month.
Time Frame
1 year
Title
Asthma Quality of Life Questionnaire(AQLQ)
Description
patients will fill out the AQLQ questionnaire on their own，and the AQLQ Scores will be calculated to show their quality of life.
Time Frame
1 year
Title
Correct answer rate of the given asthma awareness questions
Description
patients will answer 4 questions about asthma, correct answer rate will be calculated to show their awareness of asthma.
Time Frame
1 year
Title
Fractional exhaled nitric oxide(FeNO)
Description
patients will accomplish the fractional exhaled nitric oxide test，and the result of fractional exhaled nitric oxide related to airway inflammation.
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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.
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34983109
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.
Results Reference
derived
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National Mobile Asthma Management System-E Project
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