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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00842387
First received: February 11, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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
Reflux
Heartburn
Regurgitation
Esophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Treatment response and symptomatic control (Norway) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Symptom relief and patient satisfaction with treatment (Spain) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Symptom relief measured by RDQ (Sweden) [ Time Frame: 5 months +/- 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2370
Study Start Date: January 2009
Study Completion Date: December 2009
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with symptoms suggestive of GERD.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842387

  Show 66 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mónica Tafalla, MD Medical DepartmentAstraZeneca Spain
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rick Lones, European Medical Affairs Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00842387     History of Changes
Other Study ID Numbers: NIS-GEU-DUM-2008/1
Study First Received: February 11, 2009
Last Updated: December 22, 2009
Health Authority: Austria: Agency for Health and Food Safety
Italy: Ethics Committee
Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Spain: Ethics Committee
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
gastroesophageal reflux disease
reflux, heartburn
regurgitation
acid control
PPI
antiacid
primary care
esophagitis

Additional relevant MeSH terms:
Esophagitis
Gastroesophageal Reflux
Heartburn
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroenteritis
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014