Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication

NCT ID: NCT02833623

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-01-31

Brief Summary

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Helicobacter pylori (H. pylori) is a pathogen that infects more than 50% of the human population, resulting in high healthcare costs worldwide. However, H. pylori eradication rate is low nowadays and patients's compliance is one of the most important effective factors.

Detailed Description

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Conditions

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Helicobacter Pylori Eradication Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Short-message-based Re-education group

Patients receive oral and written education before H. pylori eradication therapy at first, then they receive short message re-education twice per day during therapy.

Both the content of the oral and written education and the short message re-education are same.

Group Type EXPERIMENTAL

Short-message-based Re-education

Intervention Type BEHAVIORAL

conventional education group

Patients only receive oral and written education before H. pylori eradication therapy.

Group Type ACTIVE_COMPARATOR

conventional education

Intervention Type BEHAVIORAL

Interventions

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Short-message-based Re-education

Intervention Type BEHAVIORAL

conventional education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* outpatients aged 18-70 years
* confirmed diagnosis of H. pylori infection by at least one of the following methods: 13C-urea breath test, histology, rapid urease test or bacterial culture
* an intention of H. pylori eradication treatment and have written inform consent
* ability to read short messages on the mobile phone

Exclusion Criteria

* advanced chronic disease that would not allow the patient to complete the treatment or follow-up or attend visits
* allergy to any of the drugs used in this study
* previous Helicobacter Pylori eradication treatment
* pregnancy or breastfeeding (female participants with childbearing potential were required to use medically accepted contraception for the duration of the study)
* taking antibiotics or PPIs or bismuth salts within four weeks
* previous gastrointestinal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD,PhD

Role: CONTACT

86-531-82169236

Facility Contacts

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yanqing li, MD. PhD.

Role: primary

86-531-82169236 ext. 82169508

Other Identifiers

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2016SDU-QILU-07

Identifier Type: -

Identifier Source: org_study_id

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