Asthma
Conditions
Keywords
asthma, m-health, asthma control, self-management
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.
Interventions
BEHAVIORALMobile Asthma Management System
Patients in this group use a smartphone app in their asthma self-management.
BEHAVIORALtraditional Asthma Management System
Patients in this group use a printed asthma diary in their asthma self-management.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of good adherence at the 6th month | 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
| Measure | Time frame | Description |
|---|---|---|
| Forced vital capacity(FVC) | 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. |
| Peak expiratory flow(PEF) | 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. |
| Emergency visits | 1 year | patients will report their times of emergency visits to the researchers. |
| Hospitalization | 1 year | patients will report their times of hospitalization to the researchers. |
| Fractional exhaled nitric oxide(FeNO) | 1year | patients will accomplish the fractional exhaled nitric oxide test，and the result of fractional exhaled nitric oxide related to airway inflammation. |
| Proportion of good adherence | 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. |
| Asthma Quality of Life Questionnaire(AQLQ) | 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. |
| Correct answer rate of the given asthma awareness questions | 1 year | patients will answer 4 questions about asthma, correct answer rate will be calculated to show their awareness of asthma. |
| Forced expiratory volume in one second（FEV1） | 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.) |
| Asthma Control Test（ACT） | 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. |
Countries
China
Outcome results
None listed