Telephone-Based Re-education for Hp Eradication

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Behavioral: telephone-based re-education; Behavioral: First education at the clinic

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an JiaoTong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: telephone-based re-education; 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.; Behavioral: First education at the clinic; Patients will receive an instruction card about the drug administration at the clinic by doctors.
Active Comparator: 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	Behavioral: First education at the clinic; Patients will receive an instruction card about the drug administration at the clinic by doctors.

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Shuixiang He, MD, PhD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

General Publications

• Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
• McColl KE. Clinical practice. Helicobacter pylori infection. N Engl J Med. 2010 Apr 29;362(17):1597-604. doi: 10.1056/NEJMcp1001110. No abstract available.
• Malfertheiner P, Sipponen P, Naumann M, Moayyedi P, Megraud F, Xiao SD, Sugano K, Nyren O; Lejondal H. pylori-Gastric Cancer Task Force. Helicobacter pylori eradication has the potential to prevent gastric cancer: a state-of-the-art critique. Am J Gastroenterol. 2005 Sep;100(9):2100-15. doi: 10.1111/j.1572-0241.2005.41688.x.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: June 17, 2017
• First Submitted That Met QC Criteria: June 17, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: helicobactor pylori
• Other Study ID Numbers: XAJTU-DG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No