Telephone-Based Re-education for Hp Eradication

NCT03193450 | Completed

• 1 other identifier: XAJTU-DG001
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

helicobactor pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptoms relief rate

  4-6 weeks after the end of drug administration

• Adverse events

  4-6 weeks after the end of drug administration

Study Arms (2)

Re-education group

EXPERIMENTAL

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; Behavioral: First education at the clinic

Non re-education group

ACTIVE COMPARATOR

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

Interventions

telephone-based re-education BEHAVIORAL

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.

Re-education group

First education at the clinic BEHAVIORAL

Patients will receive an instruction card about the drug administration at the clinic by doctors.

Non re-education group; Re-education group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (3)

• 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.

  PMID: 20427808 BACKGROUND

• 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.

  PMID: 16128957 BACKGROUND

• 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.

  PMID: 3123181 BACKGROUND

Study Officials

• Shuixiang He, MD, PhD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Gastroenterology

Study Record Dates

• First Submitted: June 17, 2017
• First Posted: June 20, 2017
• Study Start: October 18, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)