Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Hp eradication rate
研究概览
简要总结
It was suggested that the patient compliance plans an important role in the Hp eradication. However, data on whether re-education could improve the eradication rate are lacking. We consider that re-education on patients by telephone during the process of drug administration could increase the eradication rate in Hp infected patients.
We hypothesized that telephone re-education during the whole process of drug administration would improve the compliance of patients and ultimately increase the Hp eradication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- 否
入选标准
- •Prior informed consent
- •18-70 years of age
- •Hp infected patients diagnosed by 13C urea breath test, including digestive ulcer, gastritis with dyspepsia symptoms, family history of gastric cancer, planning to use long-term non-steroidal anti-inflammatory drugs (NSAIDs), or personal request
- •Ability to swallow oral medications
- •No contraindication for the drugs used for Hp eradication
- •Both men and women enrolled in this trial must use adequate barrier birth control during the course of the trial and 4 weeks after the completion of trial
排除标准
- •Pregnant or breast-feeding subjects
- •Previous failed treatment of Hp eradication
- •Previous treatment with bismuth salts or antibiotics within 1 month before study enrollment, and treatment with proton pump inhibitor or H2 receptor antagonist within 2 weeks before study enrollment
- •Any disease that could jeopardize the safety of subject and their compliance in the study (e.g. serious liver disease, heart disease, kidney disease, malignant tumor or alcoholism, etc.)
- •Previous upper gastrointestinal surgery
- •Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
- •Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
- •Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
研究组 & 干预措施
Re-education group
Patients in this arm will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
干预措施: First education at the clinic (Behavioral)
Re-education group
Patients in this arm will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
干预措施: telephone-based re-education (Behavioral)
Non re-education group
Patients in this arm only received an instruction card about the drug administration at the clinic by doctors but no re-education by telephone during treatment
干预措施: First education at the clinic (Behavioral)
结局指标
主要结局
Hp eradication rate
时间窗: 4-6 weeks after the end of drug administration
Eradication rate is the proportion of patients with eradicated-Hp. Hp infection was considered eradicated when negative results were obtained by 13carbon urea breath test at 4-6 weeks after the end of drug administration
次要结局
- Symptoms relief rate(4-6 weeks after the end of drug administration)
- Adverse events(4-6 weeks after the end of drug administration)
研究者
He Shuixiang
Director of the Department of Gastroenterology
First Affiliated Hospital Xi'an Jiaotong University