Telephone-Based Re-education for Hp Eradication

Xi'an Jiaotong University

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Behavioral: telephone-based re-education; Behavioral: First education at the clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT03193450

XAJTU-DG001

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 2 patient groups

Re-education group

Experimental group

Description:

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.

Treatment:

Behavioral: First education at the clinic

Behavioral: telephone-based re-education

Non re-education group

Active Comparator group

Description:

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

Treatment:

Behavioral: First education at the clinic