Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- The difference of H. pylori eradication rate between two groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Short-message-based Re-education group
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.
Intervention: Short-message-based Re-education (Behavioral)
conventional education group
Patients only receive oral and written education before H. pylori eradication therapy.
Intervention: conventional education (Behavioral)
Outcomes
Primary Outcomes
The difference of H. pylori eradication rate between two groups
Time Frame: 8 months
Secondary Outcomes
- Rate of non-compliance with instructions between 2 groups(8 months)
Investigators
Yanqing Li
Vice president of Qilu Hospital
Shandong University