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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Inhaler Technique
研究概览
简要总结
To investigate the effectiveness of addition of recording video of the patient performing inhaler techniques using mobile phone for discussion with the patient, to standard care inhaler education compared to standard care inhaler education alone, in improving inhaler technique of asthma patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcome assessment - inhaler technique assessment and asthma control questionnaire will be administered by a blinded assessor.
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
- •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
排除标准
- •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
结局指标
主要结局
Inhaler Technique
时间窗: 6 months
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
次要结局
- Inhaler Technique Error(1, 3 and 6 months)
- Asthma Control(1, 3 and 6 months)
- Inhaler Technique(1 and 3 months)
研究者
Choon Seong Ang
Research Physician, Clinical Research Centre
Penang Hospital, Malaysia