An In-depth Understanding of Determinants of Inhaled ICS Treatment Compliance of Asthma Patients: Generate Data From Structured Patient Interview & Cross Sectional Survey
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 主要终点
- MARS-A scale
研究概览
简要总结
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.
详细描述
Study site(s) and number of subjects planned 8 level-3 hospitals across West China will participate in this study. 40 not well controlled asthma patients will participate the structured interview in stage1 and a total number of 300 patients are expected to participate cross sectional survey in stage 2.
Study period Estimated Time CSP approved Oct. 2016 First subject in Jan. 2017 Last subject in Aug. 2017 Database lock Dec. 2017 CSR Mar. 2017
Study design It is study including 2 stage, stage 1 of structured patient interview by investigators, Stage 2 of a multi-center, cross-sectional survey. 40 eligible asthma patients and/or their family supporter will be invited to participate in a one-time face to face structured interview in stage 1. Around 350 eligible asthma patients will be invited to participate in cross sectional survey which all Information and relevant data of their compliance to inhaled treatment therapy and response to measurement of compliance risk factors (determinants explored from stage 1) will be collected according to CRF, and inputted into an on-line electronic questionnaire data capture (EDC) system by site investigator(s), and valid data will be taken into statistical analyses.
Target subject population Stage 1: Asthmatic patients with in adequate asthma control (defined by GINA partly or un-control due to inhaled treatment compliance (physician judgement) Stage 2: Asthmatic patient who visit the outpatient clinic will be interviewed by investigator.
Objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
- •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.
- •Other conditions judged by investigator as unsuitable for this study
结局指标
主要结局
MARS-A scale
时间窗: Mar.2017-Dec,2017
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
次要结局
- MARS-A scale of group patients age in 18- 30, age in 31-45, age in 45-60, age above 60(Mar.2017-Dec,2017)
研究者
Li Manxiang
Director, Respiratory department
First Affiliated Hospital Xi'an Jiaotong University