Assessment of Asthma Control Level in Primary Care Setting in Malaysia (ASCOPE)
2019年5月30日 更新者：AstraZeneca
A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.
A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia.
The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.
研究概览
地位
完全的
条件
详细说明
Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge.
According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%.
Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management.
There is limited data to assess the level of asthma control at the Primary Care Setting in Malaysia which includes current clinical manifestation and future risk of exacerbation.
Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment.
The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients.
研究类型
观察性的
注册 (实际的)
1011
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Negeri Sembilan
-
Port Dickson、Negeri Sembilan、马来西亚
- Research Site
-
Seremban、Negeri Sembilan、马来西亚
- Research Site
-
-
Penang
-
George Town、Penang、马来西亚
- Research Site
-
-
Perak
-
Pantai Remis、Perak、马来西亚
- Research Site
-
-
Sabah
-
Kota Kinabalu、Sabah、马来西亚
- Research Site
-
-
Sarawak
-
Asajaya、Sarawak、马来西亚
- Research Site
-
-
Selangor
-
Banting、Selangor、马来西亚
- Research Site
-
Rawang、Selangor、马来西亚
- Research Site
-
-
Terengganu
-
Bandar Permaisuri、Terengganu、马来西亚
- Research Site
-
Kuala Terengganu、Terengganu、马来西亚
- Research Site
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Outpatients seen and treated by health care providers at government health clinics.
描述
Inclusion Criteria:
- Malaysians who have been diagnosed with Asthma by a physician verified by an investigator and seen at government health clinic (Klinik Kesihatan) from October - December 2017
- Be at least 18 years of age
Exclusion Criteria:
- Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
- Pregnancy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
GINA-defined clinical diagnosis of Asthma
All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from October to December 2017 with age 18 and above
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Level of GINA-defined asthma control
大体时间：up to 8 months
|
GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment.
Patient's are classified as controlled, partially controlled or uncontrolled.
|
up to 8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
用于控制哮喘的药物类型
大体时间：长达 8 个月
|
用于哮喘控制的药物管理
|
长达 8 个月
|
|
Asthma control level
大体时间：up to 8 months
|
Asthma control is evaluated by patients' self-completion of the Asthma Control Test (ACT).
The ACT is a reliable, valid tool that helps physicians identify patients with uncontrolled asthma in a clinical setting.
The questionnaire assesses the frequency of asthma symptoms and patients' own perception of asthma control during the previous 4 weeks.
Based on the sum of scores, complete asthma control (25 points), well-controlled asthma (20-24 points) or no asthma control (≤19 points) is revealed.
|
up to 8 months
|
|
Adherence level in patients with inhalers
大体时间：up to 8 months
|
Adherence level measured by Malaysia Medication Adherence Scale (MALMAS) The first item of the MALMAS has five responses: (1) All the time, (2) Often, (3) Sometimes, (4) Rarely and (5) Never. The remaining seven items have a dichotomous response of "Yes" or "No". The responses in the MALMAS were scored based on the MMAS-8 where the total score ranged from 0 to 8. Both instruments categorized medication adherence based on the total scores obtained: low adherence (total score<6), medium adherence (6 to < 8) and high adherence (total score = 8) |
up to 8 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月23日
初级完成 (实际的)
2018年6月6日
研究完成 (实际的)
2018年6月6日
研究注册日期
首次提交
2019年1月14日
首先提交符合 QC 标准的
2019年1月14日
首次发布 (实际的)
2019年1月15日
研究记录更新
最后更新发布 (实际的)
2019年5月31日
上次提交的符合 QC 标准的更新
2019年5月30日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.