NCT00842387

Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,370 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to compare the GERD clinical outcomes in patients where a structured pathway using the GerdQ questionnaire is implemented compared with the clinical outcomes of those treated without this implementation. This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and Sweden). Due to different characteristics regarding the actual management of this disease in the 5 countries, each country had the flexibility to introduce design differences and changes in the study protocol.

Detailed description

In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists. In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group). In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines. In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.

Conditions

• Reflux
• Heartburn
• Regurgitation
• Esophagitis

Timeline

• Start date: 2009-01-01
• Completion: 2009-12-01
• First posted: 2009-02-12
• Last updated: 2009-12-23

Locations

66 sites across 5 countries: Austria, Italy, Norway, Spain, Sweden