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From the Biomedical to the Biopsychosocial Model, From Theory to Practice

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Fernando Soares Guedes, Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456273
First Posted: October 20, 2011
Last Update Posted: October 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Information provided by (Responsible Party):
Fernando Soares Guedes, Faculdade de Medicina do ABC
  Purpose
This study aims to evaluate, in patients with functional dyspepsia, a model example of medical care based upon the biopsychosocial model (called: the therapeutic encounter) compared with standard medical care based upon the biomedical model (called: medical consultation).

Condition Intervention
Functional Dyspepsia Procedure: Traditional Medical Consultation Procedure: Therapeutic Encounter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia

Resource links provided by NLM:


Further study details as provided by Fernando Soares Guedes, Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment. [ Time Frame: between four to six months of treatment ]

Estimated Enrollment: 200
Study Start Date: March 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A2- Medical consultation + placebo
Traditional medical interview + placebo
Procedure: Traditional Medical Consultation
Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole
Active Comparator: B1 - Therapeutic Encounter / Omeprazol Procedure: Therapeutic Encounter
Group B (who receive care "Therapeutic Encounter") will be divided in subgroup B1, which will receive the "Drug Therapy Classic" and 2 in group B who received placebo.
Placebo Comparator: B2 - Therapeutic Encounter / Placebo Procedure: Therapeutic Encounter
Group B (who receive care "Therapeutic Encounter") will be divided in subgroup B1, which will receive the "Drug Therapy Classic" and 2 in group B who received placebo.
Active Comparator: A1- Medical consultation + omeprazole
Traditional medical interview + omeprazole
Procedure: Traditional Medical Consultation
Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of functional dyspepsia (according to the Rome II criteria)
  • They must be literate so they can read and fill out the questionnaire and a diary of symptoms without the aid of others

Exclusion Criteria:

  • Patients who for any reason: not accepting to participate in research, not having signed an informed consent or not answering the questionnaire, the collection period, for whatever reasons
  • Abuse or dependence on alcohol, tobacco, medications or other drugs (licit or illicit)
  • Diabetes (any type
  • pregnancy or breastfeeding (in any stage of the study)
  • organic diseases or severe metabolic or evolving (heart disease, severe hypertension, infectious diseases)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456273


Contacts
Contact: Fernando S Guedes, Master 5511-7760-4287 amarelodosol@yahoo.com.br
Contact: Wilson R Catapani, Doctoral 5511-49935416 w.gastro@terra.com.br

Locations
Brazil
Faculdade de Medicina do ABC Recruiting
Santo André, São Paulo, Brazil, 09060-870
Contact: Fernando S Guedes, Master    5511-7760-4287    amarelodosol@yahoo.com.br   
Contact: Wilson R Catapani, Doctor    5511-4993-5416    w.gastro@terra.com.br   
Principal Investigator: Fernando S Guedes, Master         
Sub-Investigator: Wilson R Catapani, Doctor         
Sponsors and Collaborators
Faculdade de Medicina do ABC
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Investigators
Principal Investigator: Fernando S Guedes, Master Faculdade de Medicina do ABC
  More Information

Responsible Party: Fernando Soares Guedes, Professor, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT01456273     History of Changes
Other Study ID Numbers: Guedes, FG 01
First Submitted: August 23, 2011
First Posted: October 20, 2011
Last Update Posted: October 20, 2011
Last Verified: October 2011

Keywords provided by Fernando Soares Guedes, Faculdade de Medicina do ABC:
biopsychosocial model
biomedical model
functional dyspepsia

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action