Clinical trial NCT00842387: Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
Official title: Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reflux
Heartburn
Regurgitation
Esophagitis
Keywords: gastroesophageal reflux disease
reflux, heartburn
regurgitation
acid control
PPI
antiacid
primary care
esophagitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 2370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptoms suggestive of GERD.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy).
timeFrame: up to 8 weeks
measure: Treatment response and symptomatic control (Norway)
timeFrame: up to 8 weeks
measure: Symptom relief and patient satisfaction with treatment (Spain)
timeFrame: up to 8 weeks
measure: Symptom relief measured by RDQ (Sweden)
timeFrame: 5 months +/- 4 weeks
Secondary outcomes:
measure: 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)
timeFrame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
measure: 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)
timeFrame: Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks
measure: 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.
timeFrame: 5 months +/- 4 weeks
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Research Site
city: Baden
country: Austria
facility: Research Site
city: Bludenz
country: Austria
facility: Research Site
city: Bregenz
country: Austria
facility: Research Site
city: Feldbach
country: Austria
facility: Research Site
city: Gmunden
country: Austria
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Gross Gerungs
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Kitzbuhel
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Krems
country: Austria
facility: Research Site
city: Kufstein
country: Austria
facility: Research Site
city: Leibnitz
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Mattersburg
country: Austria
facility: Research Site
city: Mistelbach
country: Austria
facility: Research Site
city: Murzzuschlag
country: Austria
facility: Research Site
city: Neunkirchen
country: Austria
facility: Research Site
city: Neusiedl
country: Austria
facility: Research Site
city: Perg
country: Austria
facility: Research Site
city: Schwaz
country: Austria
facility: Research Site
city: St. Veit
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Villach
country: Austria
facility: Research Site
city: Vocklabruck
country: Austria
facility: Research Site
city: Volkermarkt
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Zell
country: Austria
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Aalesund
country: Norway
facility: Research Site
city: Arendal
country: Norway
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodo
country: Norway
facility: Research Site
city: Haugesund
country: Norway
facility: Research Site
city: Kristiansund
country: Norway
facility: Research Site
city: Levanger
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Mosjoen
country: Norway
facility: Research Site
city: Orkdal
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Tynset
country: Norway
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Arlov
country: Sweden
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Falkoping
country: Sweden
facility: Research Site
city: Farsta
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Karlshamn
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Kungsangen
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Munkedal
country: Sweden
facility: Research Site
city: Nordstan(Goteborg)
country: Sweden
facility: Research Site
city: Partille
country: Sweden
facility: Research Site
city: Pitea
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Sodertalje
country: Sweden
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trollhattan
country: Sweden
facility: Research Site
city: Vannas
country: Sweden
facility: Research Site
Study officials:
affiliation: Medical DepartmentAstraZeneca Spain
name: Mónica Tafalla, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.