Asthma, Allergic Clinical Trial
Official title:
An In-depth Understanding of Determinants of Inhaled ICS Treatment Compliance of Asthma Patients: Generate Data From Structured Patient Interview & Cross Sectional Survey
Verified date | August 2019 |
Source | First Affiliated Hospital Xi'an Jiaotong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The introduction of inhaled medication as the primary treatment for asthma has led to
substantial improvements in asthma control [1, 2]. However, uncontrolled asthma is still
common and represents a considerable burden to patients and society [3, 4]. An important
reason for poor asthma control and consequently, increased healthcare expenditure is
suboptimal adherence to the prescribed regimen [5-7].
Real-world market research study in hospitals across China reported that physicians perceived
that only 23% of patients were fully compliant with their medication regime (77%
non-adherent), compared to 55% in the European Union and 63% in the US [AZ internal
document]. The physician reported rate of full adherence was lower than the patient-reported
rate (38%). Poor patient adherence was the challenge most frequently mentioned (by 41% of
physicians) when treating an asthma.[8]
However
There is some evidence on the drivers of patient behaviour around low adherence but more
depth research is needed
There is little evidence on variation of determinants of asthma inhaled treatment across
different age of group
Our research aims to address above data gap Mean while this research can guide the
development of new module on Red Scarf patient education program.
Status | Completed |
Enrollment | 350 |
Est. completion date | January 20, 2018 |
Est. primary completion date | January 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criterias: 1. Age =18 years old 2. Living in the city same as the study site for a minimum period of two years 3. Having China city residence medical insurance 4. A history of at least one year of diagnosed asthma who should be on ICS or ICS/LABA inhalation treatment based on the criteria established by GINA. 5. Patients On inhaled ICS or ICS/LABA treatment regard less of compliance level in the past 6 months 6. Subjects who are willing to sign the informed consent. Exclusion Criteria: 1. Patients with active cardio or pulmonary disease such as bronchiectasis, COPD, cystic fibrosis, pulmonary tuberculosis, lung cancer, severe heart disease, etc.; other disorder such as HIV/AIDS, etc; or therapy that according to the physician could interfere with the aim of the study. 2. Patients with mental or neurological diseases, or due to alcohol or other drug abuse, that may be incapable to understand and answer the question honestly, or unwilling to do so. 3. Other conditions judged by investigator as unsuitable for this study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | AstraZeneca |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MARS-A scale | MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk factors (determinants explored from stage 1) measurements response from asthma patients | Mar.2017-Dec,2017 | |
Secondary | MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60 | MARS-A scale is a valicated tool to assess inhaled treatment compliance of asthma patients Risk facto rs measurements response from asthma patients | Mar.2017-Dec,2017 |
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