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

NCT00842387 | Completed

• 1 other identifier: NIS-GEU-DUM-2008/1
• Study Type: observational
• Target: 2,370
• Locations: 5 countries
• Sites: 66

Brief 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.

Conditions

Reflux; Heartburn; Regurgitation; Esophagitis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy).

  up to 8 weeks

• Treatment response and symptomatic control (Norway)

  up to 8 weeks

• Symptom relief and patient satisfaction with treatment (Spain)

  up to 8 weeks

• Symptom relief measured by RDQ (Sweden)

  5 months +/- 4 weeks

Secondary Outcomes (3)

• 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)

  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)

  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.

  5 months +/- 4 weeks

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptoms suggestive of GERD.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (66)

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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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Related Publications (2)

• 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.

  PMID: 23426452 DERIVED

• 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.

  PMID: 22510027 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis

Study Officials

• Mónica Tafalla, MD

  Medical DepartmentAstraZeneca Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

SE (22); AU (30); IT (1); NO (12); ES (1)