Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00842387|
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : December 23, 2009
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.
|Condition or disease|
|Reflux Heartburn Regurgitation Esophagitis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2370 participants|
|Official Title:||Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)|
|Study Start Date :||January 2009|
|Actual Study Completion Date :||December 2009|
Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway
Patients with symptoms suggestive of GERD, managed according to usual clinical practice.
- Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy). [ Time Frame: up to 8 weeks ]
- Treatment response and symptomatic control (Norway) [ Time Frame: up to 8 weeks ]
- Symptom relief and patient satisfaction with treatment (Spain) [ Time Frame: up to 8 weeks ]
- Symptom relief measured by RDQ (Sweden) [ Time Frame: 5 months +/- 4 weeks ]
- Use and consumption of healthcare resources (all countries). Physicians adherence to the clinical pathway (Austria, Spain) and intrinsic characteristics of the physicians/PCC that may affect this adherence (Austria) [ Time Frame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks ]
- Percentage of patients referred to specialists (Spain). Health status based on EQ-5D measure (Norway, Sweden). Work productivity based on the WPAI-GERD questionnaire (Norway, Sweden) [ Time Frame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks ]
- Sweden: Persisting symptoms according to GerdQ, Treatment changes, Reason(s) for the patient consultation at visit 1. To explore other GERD related symptoms, To describe patients' experience of treatment/care given during the study. [ Time Frame: 5 months +/- 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842387
Show 66 Study Locations
|Study Director:||Mónica Tafalla, MD||Medical DepartmentAstraZeneca Spain|