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Completed

NCT Number: NCT00842387

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

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.

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Key information

Conditions

Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Regurgitation Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Amstetten, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Treatment response and symptomatic control (Norway)

    Time frame: up to 8 weeks

  3. Symptom relief and patient satisfaction with treatment (Spain)

    Time frame: up to 8 weeks

  4. Symptom relief measured by RDQ (Sweden)

    Time frame: 5 months +/- 4 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2009
Study completion
2009
First posted
Feb 12, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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