Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients. (RECORD)
A Randomized Control Trial to Evaluate the Effectiveness of Personalized Mobile Phone Video Recording in Addition to Standard Care Compared to Standard Care Alone in Improving Inhaler Technique Among Patients With Asthma. (RECORD)
研究概览
详细说明
This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to standard care, compared to standard care alone, in improving inhaler technique among patients with asthma.
Patients are randomised to either Personalized Video Recording with standard clinical practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio.
Subject's inhaler technique assessment is performed by using a standard checklist of steps according to the type of inhaler used by subject.
All inhaler technique assessment and asthma control questionnaire will be administered before the intervention/control treatment by a blinded assessor. Both intervention and control treatment will be administered by the same investigators.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Penang
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George Town、Penang、马来西亚、10990
- Penang General Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years old and above
- Informed consent
- Established clinical diagnosis of asthma by patient's treating doctor
- Prescribed with inhalers (any type) for therapeutic indication for at least 3 months
Exclusion Criteria:
- Unable to converse/understand Malay or English
- Not able to perform inhalation on his/her own self
- Using spacer/valved holding chamber in addition to MDI
- Not able to comply with study procedures in the opinion of investigators
- More than two different types of inhaler which require different techniques
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制
单独标准护理
|
|
|
实验性的：Intervention
Personalized Mobile Phone Video Recording in addition to Standard care
|
Subjects will be asked to perform inhaler technique while on video recording.
The video will be shown to subjects immediately during technique education session and mistakes (if any) will be pointed out to subject.
|
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 |
|---|---|---|
|
Inhaler Technique
大体时间：6 months
|
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Asthma Control
大体时间：1, 3 and 6 months
|
Mean score of Asthma Control Questionnaire (ACQ)
|
1, 3 and 6 months
|
|
Inhaler Technique
大体时间：1 and 3 months
|
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
|
1 and 3 months
|
|
Inhaler Technique Error
大体时间：1, 3 and 6 months
|
Number of errors committed by patients according to checklist
|
1, 3 and 6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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