Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU
2019年4月8日 更新者：Shabbir Syed Abdul、Taipei Medical University
About 100 (50 from TMU Hospital and 50 from Wellcome Clinic) current smokers will be recruited who contact smoke cession clinics in teaching hospitals of Taipei Medical University (TMU) and Wellcome Clinic.
They will be randomly assigned either to Usual Care (UC) or Usual Care plus 3M4Chan Intervention group (IG).
A randomized comparative effectiveness trial will be conducted.
Patient will enroll from September 2017 to May 2018.
In UC group, the physician provides a brief advice to quit during first consultation, a quit plan template, and medication prescription (Varenicline, Bupropion, Champix, Nicotinell TTS20) as decided by the physician.
IG group includes UC plus a mobile App that is programmed to push tailored messages for health concern and readiness to quit, tips for sustaining abstinence, use of interactive self-assessments, helpful cessation information.
This group of smokers will benefit from tailored cessation interventions with integrated body weight management elements that take into consideration the prevailing local and cultural influences on diet and levels of physical activity.
IG will be continued even after stopping of the UC.
研究概览
研究类型
介入性
注册 (实际的)
92
阶段
- 不适用
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
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-
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Taipei、台湾、11031
- Syed Abdul Shabbir
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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
20年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 20 years or older and approach smoke cessation clinic at TMU hospital
- Have an Android mobile phone
- Able to read Traditional Chinese
- Willing to participate in all study components
- Willing to be followed-up for 6 months
- Smoked at least once every month in the last two years
- Current smoker
Exclusion Criteria:
• Below 20 years on the day of enrolment
- Not willing to participate in the study
- Those who do not have Android mobile phone or unable to read Mandarin
- Not willing to share medical information from EHR
- Subjects who develop adverse effects related to the pharmacological treatment included in the study
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
- 主要用途：支持治疗
- 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 |
|---|---|
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有源比较器：Case
Motivational message will be administrated.
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Motivational message will be administrated.
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无干预：Control
Motivational message will not be administrated.
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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 |
|---|---|---|
|
Smoking cessation rate at two months
大体时间：Up to 2 months
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Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group.
Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
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Up to 2 months
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Smoking cessation rate at four months
大体时间：Up to 4 months
|
Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group.
Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
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Up to 4 months
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Smoking cessation rate at six months
大体时间：Up to 6 months
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Smoking cessation rate will be measured as the ratio of the total number of patients who relapsed with total number of patients in their group.
Patients will be considered to have relapsed if they fail at least one of their urine cotinine and carbon monoxide tests.
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Up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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User engagement at an individual level
大体时间：Up to 6 months
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Engagement at individual level will be assessed based on the rate of read messages by the patients.
This is calculated as the quotient between the messages the patients have read, and the total number of messages the system has sent to the patients.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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Engagement at aggregated level - Mobile application rolling retention
大体时间：Up to 6 months
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The percentage of users still active N days after installation.
This is a ratio of the number of users whose last day of activity is past day N to the number of users who could have been active on day N.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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Engagement at aggregated level - Mobile application session length distribution
大体时间：Up to 6 months
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The session length is defined as the length of time between the start of the application event and the end of the application event.
The session length determines the engagement as it is relevant to know how much time patients spend in the app per session.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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Engagement at aggregated level - Mobile application session frequency
大体时间：Up to 6 months
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The session frequency is a measure of how often each unique patient used the app within a given time interval.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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Engagement at aggregated level - Mobile application sessions per user
大体时间：Up to 6 months
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A session is one use of the mobile application by a patient.
This begins when the application is launched and ends when the application is terminated.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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Engagement at aggregated level - Mobile application return rate
大体时间：Up to 6 months
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Return rate measures the percentage of patients who return to the app on a specific time after installation.
It is measured by cohort group - that is, based on when patients first opened the app.
It is calculated as the ratio of the number of users active on a given period to the size of the cohort.
This metric will be assessed throughout the observation until its end.
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Up to 6 months
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User quitting attempts
大体时间：Up to 6 months
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Number of quitting attempts per patient, including the frequency of the quitting attempts.
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Up to 6 months
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User app behavior
大体时间：Up to 6 months
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It will be measured as the time spent per app section.
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Up to 6 months
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User satisfaction with messages
大体时间：At 6 months after enrolment.
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Patients' answers to a satisfaction questionnaire that will be handed to them at the end of the study.
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At 6 months after enrolment.
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User message ratings
大体时间：Up to 6 months
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User's votes for each message in a 5 star scale.
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Up to 6 months
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User lifestyle feedback
大体时间：At enrollment and at 6 months after enrollment
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Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire EQ-5D-5L.
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At enrollment and at 6 months after enrollment
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User lifestyle feedback
大体时间：At enrollment and at 6 months after enrollment
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Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaire IPAQ for physical activity.
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At enrollment and at 6 months after enrollment
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User lifestyle feedback
大体时间：At enrollment and at 6 months after enrollment
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Comparison of changes in user lifestyle (at baseline and after 6 months) through the combined questionnaires SF-36.
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At enrollment and at 6 months after enrollment
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Physical activity
大体时间：Up to 6 months
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The physical activity would be measured as the total time (minutes) of activity per user, retrieved by GoogleFit in the app.
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Up to 6 months
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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。
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。
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9月1日
初级完成 (实际的)
2019年3月2日
研究完成 (实际的)
2019年3月15日
研究注册日期
首次提交
2017年3月24日
首先提交符合 QC 标准的
2017年4月5日
首次发布 (实际的)
2017年4月11日
研究记录更新
最后更新发布 (实际的)
2019年4月10日
上次提交的符合 QC 标准的更新
2019年4月8日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
其他研究编号
- N201702069
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不
研究美国 FDA 监管的设备产品
不
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.
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