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临床试验/NCT02833623
NCT02833623Unknown4 期

Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication

Shandong University1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
310
试验地点
1
主要终点
The difference of H. pylori eradication rate between two groups

研究概览

简要总结

Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •outpatients aged 18-70 years
  • •confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
  • •an intention of H. pylori eradication treatment and have written inform consent
  • •ability to read short messages on the mobile phone

排除标准

  • •advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
  • •allergy to any of the drugs used in this study
  • •previous Helicobacter Pylori eradication treatment
  • •pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
  • •taking antibiotics or PPIs or bismuth salts within four weeks
  • •previous gastrointestinal surgery

研究组 & 干预措施

Short-message-based Re-education group

Experimental

Patients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy.

Both the content of the oral and written education and the short message re-education are same.

干预措施: Short-message-based Re-education (Behavioral)

conventional education group

Active Comparator

Patients only receive oral and written education before H. pylori eradication therapy.

干预措施: conventional education (Behavioral)

结局指标

主要结局

The difference of H. pylori eradication rate between two groups

时间窗: 8 months

次要结局

  • Rate of non-compliance with instructions between 2 groups(8 months)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Vice president of Qilu Hospital

Shandong University

研究点 (1)

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