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

NCT ID: NCT00842387

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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

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Reflux Heartburn Regurgitation Esophagitis

Keywords

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gastroesophageal reflux disease reflux, heartburn regurgitation acid control PPI antiacid primary care esophagitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with symptoms suggestive of GERD, managed according to a new structured and implemented pathway

No interventions assigned to this group

2

Patients with symptoms suggestive of GERD, managed according to usual clinical practice.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Mónica Tafalla, MD

Role: STUDY_DIRECTOR

Medical DepartmentAstraZeneca Spain

Locations

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Amstetten, , Austria

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Baden, , Austria

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Bludenz, , Austria

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Bregenz, , Austria

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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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Kitzbühel, , Austria

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Klagenfurt, , Austria

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Krems, , Austria

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Kufstein, , Austria

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Leibnitz, Styria, , 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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Mürzzuschlag, , Austria

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Neunkirchen, , Austria

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Neusiedl, , Austria

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Perg, , Austria

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Sankt Veit im Pongau, , Austria

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Schwaz, , Austria

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Steyr, , Austria

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Villach, , Austria

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Vöcklabruck, , Austria

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Völkermarkt, , Austria

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Wels, , Austria

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Zell, , Austria

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Brescia, , Italy

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Arendal, , Norway

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Ålesund, , Norway

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Bergen, , Norway

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Bodø, , 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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Mosjøen, , Norway

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Orkdal, , Norway

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Oslo, , Norway

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Tynset, , Norway

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Valencia, , Spain

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Arlöv, , Sweden

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Dalby, , Sweden

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Falköping, , Sweden

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Farsta, , Sweden

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Gothenburg, , Sweden

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Helsingborg, , Sweden

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Karlshamn, , Sweden

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Kristianstad, , Sweden

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Kungsängen, , Sweden

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Luleå, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Munkedal, , Sweden

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Nordstan(Goteborg), , Sweden

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Partille, , Sweden

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Piteå, , Sweden

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Skanör, , Sweden

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Solna, , Sweden

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Södertälje, , Sweden

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Stockholm, , Sweden

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Trollhättan, , Sweden

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Vännäs, , Sweden

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Countries

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Austria Italy Norway Spain Sweden

References

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Bergquist H, Agreus L, Tillander L, Johnsson F, Sorngard H, Sjostedt S, Hellstrom PM. Structured diagnostic and treatment approach versus the usual primary care approach in patients with gastroesophageal reflux disease: a cluster-randomized multicenter study. J Clin Gastroenterol. 2013 Aug;47(7):e65-73. doi: 10.1097/MCG.0b013e31827d7782.

Reference Type DERIVED
PMID: 23426452 (View on PubMed)

Jonasson C, Moum B, Bang C, Andersen KR, Hatlebakk JG. Randomised clinical trial: a comparison between a GerdQ-based algorithm and an endoscopy-based approach for the diagnosis and initial treatment of GERD. Aliment Pharmacol Ther. 2012 Jun;35(11):1290-300. doi: 10.1111/j.1365-2036.2012.05092.x. Epub 2012 Apr 18.

Reference Type DERIVED
PMID: 22510027 (View on PubMed)

Other Identifiers

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NIS-GEU-DUM-2008/1

Identifier Type: -

Identifier Source: org_study_id