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

NCT02833623 | Unknown Phase 4 DMC

• 1 other identifier: 2016SDU-QILU-07
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Helicobacter Pylori Eradication Rate

Keywords

Helicobacter Pylori eradication rate; Efficacy of Short-message-based Re-education (SMRE)

Outcome Measures

Primary Outcomes (1)

• The difference of H. pylori eradication rate between two groups

  8 months

Secondary Outcomes (1)

• Rate of non-compliance with instructions between 2 groups

  8 months

Other Outcomes (2)

• The different rate of adverse events between 2 groups

  8 months

• The different rate of symptom remissions after Hp eradication therapy between 2 groups

  8 months

Study Arms (2)

Short-message-based Re-education group

EXPERIMENTAL

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.

Behavioral: Short-message-based Re-education

conventional education group

ACTIVE COMPARATOR

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

Behavioral: conventional education

Interventions

Short-message-based Re-education BEHAVIORAL

Short-message-based Re-education group

conventional education BEHAVIORAL

conventional education group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Study Officials

• Yanqing Li, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD,PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 14, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

CN (1)