Efficacy of Short-message-based Re-education (SMRE) on He... | NCT02833623

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

NCT02833623

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Oct 14, 2016Estimated

Enrollment

310Estimated

Phase

Phase 4

Conditions

Helicobacter Pylori Eradication Rate

Interventions

Short-message-based Re-education
conventional education

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Jul 7, 2016

First Submission Date that Met QC Criteria

Jul 12, 2016

First Posted Date

Jul 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Short-message-based Re-education	Behavioral		Short-message-based Re-education group
conventional education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference of H. pylori eradication rate between two groups		8 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of non-compliance with instructions between 2 groups		8 months

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, MD,PhD	Contact	86-531-82169236		liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD,PhD	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China