The Impact of WeChat Group Patient Education on the Eradication Rate of Helicobacter Pylori

NCT04850209 | Completed

• 1 other identifier: 2021SDU-QILU-067
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, effects of oral and written education, WeChat education plus oral and written education on Helicobacter pylori eradication will be compared in a randomized way.

Conditions

Helicobacter Pylori Infection; Helicobacter Pylori Eradication; Patient Education

Keywords

helicobacter pylori; eradication; patient education; Wechat group

Outcome Measures

Primary Outcomes (1)

• eradication rate in each group

  Six weeks after completion of treatment，number 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 (1)

• prevalence of adverse events

  14 days

Other Outcomes (1)

• compliance of patients in the two groups

  14 days

Study Arms (2)

Control group

OTHER

Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg , amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education

Other: oral and written education

Wechat group

EXPERIMENTAL

Patients in this group will receive clarithromycin based bismuth-containing quadruple therapy, Vonoprazan fumarate 20 mg, colloidal bismuth pectin capsule 200 mg ,amoxicillin 1000 mg and clarithromycin 500 mg, twice daily, 14 days.Patients will receive oral and written education. And patients will be invited into a Wechat group to obtain interactive education through question and answer,which is provided by medical professionals.

Other: oral and written education; Other: Wechat group

Interventions

oral and written education OTHER

oral and written education

Control group; Wechat group

Wechat group OTHER

Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional

Wechat group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 75 years old;
• H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.

You may not qualify if:

• previous therapy for H. pylori;
• with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study;
• history of gastric surgery,
• pregnancy or lactation;
• the use of PPI or antibiotics during the 4 weeks prior to enrolment;
• previous history of allergic reactions to any of the medications used in this protocol;
• unable to use smartphone and wechat
• unwilling or incapable to provide informed consents.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 257000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The interventions are blind to follow-up personnel who collect and analyze compliance and the incidence of adverse events. The interventions are also blind to the UBT personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of gastroenterology department of Qilu hospital

Model Details: There are two randomized parallel groups in this study, control group and Wechat group.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 20, 2021
• Study Start: July 23, 2021
• Primary Completion: August 10, 2022
• Study Completion: September 10, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)