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

December 22, 2009 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Amstetten, Austria
    - Research Site
  - Baden, Austria
    - Research Site
  - Bludenz, Austria
    - Research Site
  - Bregenz, Austria
    - Research Site
  - Feldbach, Austria
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  - Gmunden, Austria
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  - Graz, Austria
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  - Gross Gerungs, Austria
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  - Innsbruck, Austria
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  - Kitzbuhel, Austria
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  - Klagenfurt, Austria
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  - Krems, Austria
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  - Kufstein, Austria
    - Research Site
  - Leibnitz, Austria
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  - Leoben, Austria
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  - Linz, Austria
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  - Mattersburg, Austria
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  - Mistelbach, Austria
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  - Murzzuschlag, Austria
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  - Neunkirchen, Austria
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  - Neusiedl, Austria
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  - Perg, Austria
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  - Schwaz, Austria
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  - St. Veit, Austria
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  - Steyr, Austria
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  - Villach, Austria
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  - Vocklabruck, Austria
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  - Volkermarkt, Austria
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  - Wels, Austria
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  - Zell, Austria
    - Research Site
Italy
- - Brescia, Italy
    - Research Site
Norway
- - Aalesund, Norway
    - Research Site
  - Arendal, Norway
    - Research Site
  - Bergen, Norway
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  - Bodo, Norway
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  - Haugesund, Norway
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  - Kristiansund, Norway
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  - Levanger, Norway
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  - Molde, Norway
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  - Mosjoen, Norway
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  - Orkdal, Norway
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  - Oslo, Norway
    - Research Site
  - Tynset, Norway
    - Research Site
Spain
- - Valencia, Spain
    - Research Site
Sweden
- - Arlov, Sweden
    - Research Site
  - Dalby, Sweden
    - Research Site
  - Falkoping, Sweden
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  - Farsta, Sweden
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  - Goteborg, Sweden
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  - Helsingborg, Sweden
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  - Karlshamn, Sweden
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  - Kristianstad, Sweden
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  - Kungsangen, Sweden
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  - Lulea, Sweden
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  - Lund, Sweden
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  - Malmo, Sweden
    - Research Site
  - Munkedal, Sweden
    - Research Site
  - Nordstan(Goteborg), Sweden
    - Research Site
  - Partille, Sweden
    - Research Site
  - Pitea, Sweden
    - Research Site
  - Skanor, Sweden
    - Research Site
  - Sodertalje, Sweden
    - Research Site
  - Solna, Sweden
    - Research Site
  - Stockholm, Sweden
    - Research Site
  - Trollhattan, Sweden
    - Research Site
  - Vannas, Sweden
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with symptoms suggestive of GERD.

Description

Inclusion Criteria:

Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity
Patient able to understand and complete the questionnaires

Exclusion Criteria:

Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding)
If the patient is participating in any clinical trial, he/she cannot take part on this study
Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway
2 Patients with symptoms suggestive of GERD, managed according to usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	up to 8 weeks
Treatment response and symptomatic control (Norway) Time Frame: up to 8 weeks	up to 8 weeks
Symptom relief and patient satisfaction with treatment (Spain) Time Frame: up to 8 weeks	up to 8 weeks
Symptom relief measured by RDQ (Sweden) Time Frame: 5 months +/- 4 weeks	5 months +/- 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	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	5 months +/- 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Study Director: Mónica Tafalla, MD, Medical DepartmentAstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria