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临床试验/NCT03108651
NCT03108651已完成不适用

Mobile Motivational Messages for Change (3M4Chan) Intervention in TMU

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Smoking cessation rate at six months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Researchers do not disclose about App and messages to control group

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • • 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

研究组 & 干预措施

Case

Active Comparator

Motivational message will be administrated.

干预措施: Case (Other)

Control

No Intervention

Motivational message will not be administrated.

结局指标

主要结局

Smoking cessation rate at six months

时间窗: Up to 6 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.

Smoking cessation rate at two months

时间窗: Up to 2 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.

Smoking cessation rate at four months

时间窗: 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.

次要结局

  • User engagement at an individual level(Up to 6 months)
  • Engagement at aggregated level - Mobile application return rate(Up to 6 months)
  • User app behavior(Up to 6 months)
  • User satisfaction with messages(At 6 months after enrolment.)
  • User quitting attempts(Up to 6 months)
  • Engagement at aggregated level - Mobile application rolling retention(Up to 6 months)
  • Engagement at aggregated level - Mobile application session frequency(Up to 6 months)
  • User message ratings(Up to 6 months)
  • Physical activity(Up to 6 months)
  • Engagement at aggregated level - Mobile application session length distribution(Up to 6 months)
  • Engagement at aggregated level - Mobile application sessions per user(Up to 6 months)
  • User lifestyle feedback(At enrollment and at 6 months after enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shabbir Syed Abdul

Assistant Professor & Health IT Consultant

Taipei Medical University

研究点 (2)

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