National Mobile Asthma Management System-E Project

Asthma Clinical Trial

Official title:

National Mobile Asthma Management System-E Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917174
• Other study ID #: CARN2016-01
• Status: Completed
• Phase: N/A
• Start date: March 25, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: China-Japan Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 870
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Mobile Asthma Management System
Patients in this group use a smartphone app in their asthma self-management.
• traditional Asthma Management System
Patients in this group use a printed asthma diary in their asthma self-management.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Emergency visits	patients will report their times of emergency visits to the researchers.	1 year
Secondary	Hospitalization	patients will report their times of hospitalization to the researchers.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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