基于视频的教学目标干预对约旦哮喘和慢性阻塞性肺病患者的吸入技术
基于视频的针对哮喘和慢性阻塞性肺病成人吸入器技术的目标干预干预:一项随机对照试验
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Amman、约旦
- Jordan University Hospital
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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
纳入标准:
- 确诊为哮喘或慢性阻塞性肺病。
- 开始使用一个或多个吸入器设备至少一个月。
- 预计将继续长期使用他们的吸入器设备。
排除标准:
- 感染风险高的患者(免疫功能低下)。
- 患者表现出非常严重的临床表现(严重呼吸困难、低氧血症引起的意识模糊、需要持续氧疗)。
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:控制
标准口头教学目标吸入器技术教育
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向参与者展示了如何正确使用他们的吸入器,然后再次要求他们展示该技术。
对于每一个不正确的步骤,患者都会得到纠正,并要求他们重复这些步骤,直到他们掌握了这项技术。
这个过程最多重复三次。
其他名称:
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有源比较器:干涉
基于视频的目标吸入器技术教育
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参与者接受了基于视频的目标教学方法的教育。
使用智能手机,播放一段教育视频,说明患者使用的每种吸入器的正确技术。
观看视频后,患者被要求再次展示如何使用吸入器,并且对于每个错误的步骤再次播放视频,直到掌握正确的技术最多 3 次。
在采访结束时,干预组的参与者通过 WhatsApp 收到了一份视频副本,并被邀请在需要时观看视频。
其他名称:
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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 |
---|---|---|
使用正确吸入器技术的参与者人数
大体时间:在基线“第一次采访”
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参与者正确使用吸入器的能力:使用标准化检查表
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在基线“第一次采访”
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使用正确吸入器技术的参与者人数
大体时间:历经三个月介入“二次面试”
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参与者正确使用吸入器的能力:使用标准化检查表
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历经三个月介入“二次面试”
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
中高服药依从性的参与者人数
大体时间:在基线“第一次采访”
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使用 morisky-green levien 量表 (MGLS) 坚持吸入药物治疗哮喘或 COPD。
该量表是先前验证的用于评估药物依从性的 4 分制分数,分数从 1 增加到 4 意味着更好的药物依从性。
MGLS 为 1 的患者被认为具有低服药依从性,而得分等于或高于 2 的患者被认为具有中高水平的依从性。
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在基线“第一次采访”
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中高服药依从性的参与者人数
大体时间:经过三个月的干预“二次面试”
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使用 morisky-green levien 量表 (MGLS) 坚持吸入药物治疗哮喘或 COPD。
该量表是先前验证的用于评估药物依从性的 4 分制分数,分数从 1 增加到 4 意味着更好的药物依从性。
MGLS 为 1 的患者被认为具有低服药依从性,而得分等于或高于 2 的患者被认为具有中高水平的依从性。
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经过三个月的干预“二次面试”
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疾病控制良好的哮喘患者人数
大体时间:在基线“第一次采访”
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使用哮喘控制测试 (ACT) 评估症状频率和严重程度。 量表为 25 分,最低得分为 5 分,表示症状控制最差,最高得分为“最佳疾病控制”,得分为 25 分。 得分为 5-19 的患者被认为患有未控制的哮喘,而得分为 20-25 的患者则认为哮喘控制良好。 |
在基线“第一次采访”
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疾病控制良好的哮喘患者人数
大体时间:经过三个月的干预“二次面试”
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使用哮喘控制测试 (ACT) 评估症状频率和严重程度。 量表为 25 分,最低得分为 5 分,表示症状控制最差,最高得分为“最佳疾病控制”,得分为 25 分。 得分为 5-19 的患者被认为患有未控制的哮喘,而得分为 20-25 的患者则认为哮喘控制良好。 |
经过三个月的干预“二次面试”
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疾病控制良好的 COPD 患者人数
大体时间:在基线“第一次采访”
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使用 COPD 评估测试评估症状频率和严重程度。
40分制;随着分数的降低,疾病控制被认为更好。
得分为 0-9 的参与者被认为症状较少“COPD 控制良好”,而得分在 10-40 之间的参与者被认为症状较多“COPD 控制较差”。
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在基线“第一次采访”
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疾病控制良好的 COPD 患者人数
大体时间:经过三个月的干预“二次面试”
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使用 COPD 评估测试评估症状频率和严重程度。
40分制;随着分数的降低,疾病控制被认为更好。
得分为 0-9 的参与者被认为症状较少“COPD 控制良好”,而得分在 10-40 之间的参与者被认为症状较多“COPD 控制较差”。
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经过三个月的干预“二次面试”
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哮喘相关生活质量
大体时间:在基线“第一次采访”
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使用迷你哮喘生活质量问卷 (mini-AQLQ) 评估哮喘患者的生活质量。 一个 15 个问题的量表,每个问题的分数为 1-7。 计算平均分数以给出 1-7 之间的结果。随着平均分数从 1 增加到 7,与疾病相关的生活质量被认为更好;
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在基线“第一次采访”
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哮喘相关生活质量
大体时间:经过三个月的干预“二次面试”
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使用迷你哮喘生活质量问卷 (mini-AQLQ) 评估哮喘患者的生活质量。 一个 15 个问题的量表,每个问题的分数为 1-7。 计算平均分数以给出 1-7 之间的结果。随着平均分数从 1 增加到 7,与疾病相关的生活质量被认为更好;
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经过三个月的干预“二次面试”
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COPD 相关生活质量
大体时间:在基线“第一次采访”
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使用 St.George 呼吸问卷评估 COPD 患者的生活质量。 一个 50 项验证工具。 每个问题都有开发人员指定的特定权重,SGRQ 分数是使用同样由问卷开发人员设计和提供的自动化应用程序计算的。 因此,自动化应用程序可以产生四个最终结果;代表 COPD 对患者生活质量的总负担的总分、“症状”评分、“活动受限”评分和“影响”评分。 SGRQ 总分和三个领域中每个领域的得分范围从 0 到 100,其中得分的增加表明疾病对患者 QoL 造成的损害更大。 |
在基线“第一次采访”
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COPD 相关生活质量
大体时间:经过三个月的干预“二次面试”
|
使用 St.George 呼吸问卷评估 COPD 患者的生活质量。 一个 50 项验证工具。 每个问题都有开发人员指定的特定权重,SGRQ 分数是使用同样由问卷开发人员设计和提供的自动化应用程序计算的。 因此,自动化应用程序可以产生四个最终结果;代表 COPD 对患者生活质量的总负担的总分、“症状”评分、“活动受限”评分和“影响”评分。 SGRQ 总分和三个领域中每个领域的得分范围从 0 到 100,其中得分的增加表明疾病对患者 QoL 造成的损害更大。 |
经过三个月的干预“二次面试”
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合作者和调查者
出版物和有用的链接
一般刊物
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