Telephone-Based Re-education for Hp Eradication

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Behavioral: telephone-based re-education; Behavioral: First education at the clinic

• Registration Number: NCT03193450
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-17
• Study First Submitted QC: 2017-06-17
• Study First Posted: 2017-06-20
• Study Start: 2017-10-18
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-28
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1. Prior informed consent
2. 18-70 years of age
3. 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
4. Ability to swallow oral medications
5. No contraindication for the drugs used for Hp eradication
6. 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

1. Pregnant or breast-feeding subjects
2. Previous failed treatment of Hp eradication
3. 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
4. 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.)
5. Previous upper gastrointestinal surgery
6. Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
7. Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
8. Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Re-education group	telephone-based re-education	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.
Re-education group	First education at the clinic	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.
Non re-education group	First education at the clinic	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

Primary Outcome Measures

Name	Time	Method
Hp eradication rate	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China