Telephone-Based Re-education for Hp Eradication

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Telephone-Based Re-Education of Drug Administration for Helicobacter Pylori Eradication: a Multi-Center Randomized, Controlled Study

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Behavioral: telephone-based re-education
* Behavioral: First education at the clinic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Re-education group<br>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. | Behavioral: telephone-based re-education<br>* Patients 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.<br>Behavioral: First education at the clinic<br>* Patients will receive an instruction card about the drug administration at the clinic by doctors.<br>|
| Active Comparator: Non re-education group<br>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 | Behavioral: First education at the clinic<br>* Patients will receive an instruction card about the drug administration at the clinic by doctors.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hp eradication rate | 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 | 4-6 weeks after the end of drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms relief rate | The symptoms were recorded according to Gastrointestinal Symptom Rating Scale. | 4-6 weeks after the end of drug administration | 
| Adverse events | The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events (CTCAE: version 4.0) | 4-6 weeks after the end of drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helicobactor pylori