National Mobile Asthma Management System-E Project

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Mobile Asthma Management System; Behavioral: traditional Asthma Management System

• Study Type: Interventional
• Enrollment (Actual): 870
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mobile management; use mobile management to improve asthma control	Behavioral: Mobile Asthma Management System; Patients in this group use a smartphone app in their asthma self-management.
Other: Traditional management; use Traditional management to improve asthma control	Behavioral: traditional Asthma Management System; Patients in this group use a printed asthma diary in their asthma self-management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	1 year
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.	1 year
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.	1 year
Emergency visits	patients will report their times of emergency visits to the researchers.	1 year
Hospitalization	patients will report their times of hospitalization to the researchers.	1 year
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.	1 year
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.	1 year
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.	1 year
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.	1 year
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.	1year

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2017
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 28, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: self-management; asthma; asthma control; m-health
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: CARN2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No