Helicobacter Pylori Eradication, Helicobacter Pylori Infection, Patient Education
Conditions
Keywords
helicobacter pylori, eradication, patient education, Wechat group
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.
Detailed description
There are two randomized parallel groups in this study, control group and Wechat group.All of the patients will be treated with Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate. In control group,the patients will be educated by oral and written way about the regimen. In Wechat group, the patients will be educated by Wechat oral and written way. Then, the eradication rates, compliance, adverse events, patients' satisfaction and experience will be evaluated.
Interventions
OTHERoral and written education
oral and written education
OTHERWechat group
Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
There are two randomized parallel groups in this study, control group and Wechat group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. aged between 18 and 75 years old; 2. H. pylori infection confirmed by any two positive outcomes of rapid urease test (RUT), 13C-urea breath test (UBT) or histopathology.
Exclusion criteria
1. previous therapy for H. pylori; 2. with significant underlying disease (e.g. decompensated liver cirrhosis, renal failure or malignant tumors) that may interfere the study; 3. history of gastric surgery, 4. pregnancy or lactation; 5. the use of PPI or antibiotics during the 4 weeks prior to enrolment; 6. previous history of allergic reactions to any of the medications used in this protocol; 7. unable to use smartphone and wechat 8. unwilling or incapable to provide informed consents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eradication rate in each group | 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of adverse events | 14 days | At the follow-up,adverse events complained by patients will be recorded by an independent researcher，meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events. |
Other
| Measure | Time frame | Description |
|---|---|---|
| compliance of patients in the two groups | 14 days | compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken. |
Countries
China
Outcome results
None listed