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Completed

NCT Number: NCT02917174

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile Asthma Management System

Behavioral

Patients in this group use a smartphone app in their asthma self-management.

traditional Asthma Management System

Behavioral

Patients in this group use a printed asthma diary in their asthma self-management.

Primary outcomes

  1. Proportion of good adherence at the 6th month

    Time frame: 6 months

    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 outcomes

  1. Forced expiratory volume in one second（FEV1）

    Time frame: 1 year

    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.)

  2. Forced vital capacity(FVC)

    Time frame: 1 year

    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.

  3. Peak expiratory flow(PEF)

    Time frame: 1 year

    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.

  4. Emergency visits

    Time frame: 1 year

    patients will report their times of emergency visits to the researchers.

  5. Hospitalization

    Time frame: 1 year

    patients will report their times of hospitalization to the researchers.

  6. Asthma Control Test（ACT）

    Time frame: 1 year

    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.

  7. Proportion of good adherence

    Time frame: 1 year

    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.

  8. Asthma Quality of Life Questionnaire(AQLQ)

    Time frame: 1 year

    patients will fill out the AQLQ questionnaire on their own，and the AQLQ Scores will be calculated to show their quality of life.

  9. Correct answer rate of the given asthma awareness questions

    Time frame: 1 year

    patients will answer 4 questions about asthma, correct answer rate will be calculated to show their awareness of asthma.

  10. Fractional exhaled nitric oxide(FeNO)

    Time frame: 1year

    patients will accomplish the fractional exhaled nitric oxide test，and the result of fractional exhaled nitric oxide related to airway inflammation.

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2016
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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