NCT05186662

Brief Summary

we conducted a retrospective study to compare the efficacy of WeChat-based patient education and conventional patient education in the management of Helicobacter pylori eradication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,017

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.1 years

First QC Date

December 25, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

helicobacter pylori eradication patient education Wechat group

Outcome Measures

Primary Outcomes (1)

  • eradication rate

    Six weeks after completion of treatment,numbers of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis.

    2 months

Secondary Outcomes (2)

  • compliance

    14 days

  • prevalence of adverse events

    14 days

Study Arms (2)

WeChat group

Other: patient education

Control group

Other: patient education

Interventions

patients in experimental group were asked to join a WeChat group, which was governed by experienced gastroenterologists. Relevant knowledge of H. pylori eradication was released in the group chat irregularly. Patients in WeChat group were allowed to ask questions at any time during the whole treatment process, soon afterwards, suggestions were given.

WeChat group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients aged between 18-75 years old and had been prescribed a 14-day course of bismuth-contained quadruple therapy for H. pylori infection in our outpatient clinics between 1 July 2019 and 31 July 2021. H. pylori infection was confirmed by any two positive outcomes of rapid urease test,13C-urea breath test (UBT) and histopathology. Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded.

You may qualify if:

  • patients aged between 18 and 75 years old and have not been treated before.

You may not qualify if:

  • Patients who had H. pylori therapy history, using other therapeutic regimens or unwilling to take prescribed medications were excluded. Demographic data, treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of gastroenterology department of Qilu hospital

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 11, 2022

Study Start

July 1, 2019

Primary Completion

July 31, 2021

Study Completion

December 7, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations