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

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Traditional Medical Consultation
Therapeutic Encounter
Sponsored by
Faculdade de Medicina do ABC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring biopsychosocial model, biomedical model, functional dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculdade de Medicina do ABCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

A2- Medical consultation + placebo

B1 - Therapeutic Encounter / Omeprazol

B2 - Therapeutic Encounter / Placebo

A1- Medical consultation + omeprazole

Arm Description

Traditional medical interview + placebo

Traditional medical interview + omeprazole

Outcomes

Primary Outcome Measures

Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2011
Last Updated
October 19, 2011
Sponsor
Faculdade de Medicina do ABC
Collaborators
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
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1. Study Identification

Unique Protocol Identification Number
NCT01456273
Brief Title
From the Biomedical to the Biopsychosocial Model, From Theory to Practice
Official Title
Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Medicina do ABC
Collaborators
Feculdade de Medicina da Universidade de Sao Paulo - Brasil

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
INTRODUCTION Addressing the high costs involved in new medical technology (biotechnology) is a problem that has led individuals and public health services to feel increasingly powerless. Many authors say that not even an efficient use of resources can ensure better care and health care, a true bottomless pit. The problem is the conceptual and ideological bases of thinking and acting of the professionals involved. The first misunderstanding is the "narrow approach" and the second is the "process of medicalization." The curative model and the restricted approach The curative model gets this name because it is not concerned with the causes of the disease process (prevention), only with the effects (the disease). As the effects can be mitigated or even extinct, it is only temporary, because sooner or later they will return with the same format or not, in the same individual or another. It is extremely costly for individuals and for society, because the solutions are palliative. The approach is limited and so are results too. The process of medicalization Medicalization is the ultimate expression of the distortions of thinking and consequences of the model of health care regulations. It can be understood as the increasingly high dependence on individuals and society overestimating the role that biotechnology could play, and creating a dependency in which one believes that for any problem, regardless of its severity or causal links, there will be a life-saving treatment. The wrong postures and maintenance of unhealthy habits The model of health care can lead to wrong postures. Many of today's health problems have a direct causal relationship with the passive attitude of individuals, who delegate (to health care and biotechnology) full responsibility for treating their ailments, are reluctant to bring about changes in habits and behaviors because the "curative medicine holds that the doctors can take a magic bullet and get our problems solved." The strong interest in maintaining the healing model The curative model has a tendency to concentrate on the application of biotechnology to strengthen the multinational pharmaceutical industry and large firms in highly sophisticated biomedical equipment. This has generated a stunning increase of expenditure on health as well as strong interest in this market maintaining its hegemonic space through emphasis on "cure(medicalization of life", rather than the emphasis on prevention and changing habits. Aim of the study This study will aim to test, 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). What is the biopsychosocial model The biopsychosocial model does not focus exclusively on organic disease. It considers the thinking process of becoming ill with multiple causalities. It tries to understand the man, their psychological, biological, socio-cultural and spiritual interconnections. It argues that the way of being and becoming ill are constructions of the life history of each individual, where the psychological and physiological are inextricably linked. In this perspective, disease becomes an expression of internal conflicts, has a personal character and is linked to the person's relationship with his world (its environment). This approach has important consequences in medical practice as the doctor's focus of attention shifts to the individual diseases. The medical care based upon the biopsychosocial model conserves the characteristics of art of medicine. Art in the sense of craftsmanship (the "tailored") as opposed to biomedical technique that is (to systematize, generalize). In fact one must know deeply the technique to apply it with art. The primary focus continues to be what the patient has in common with others, but in its quirks (it is the art of medicine). It is considered less important if a particular treatment will work, thinking of the majority of patients (the technique), but whether it will work for this particular patient, with his personal problems at the moment of his life in this environment, this location in this country and this region of the world. Why test it in functional dyspepsia patients Functional dyspepsia is part of a group of diseases called "Functional Disorders of the Gastrointestinal Tract" that goes beyond the biomedical model: They are defined as variable combinations of symptoms, not explained by structural or biochemical changes. The diagnostic criteria and parameters for better or worse are based on symptoms reported by patients, this causes some skepticism in the face of more traditional medical view. There are no objective criteria for assessing these disorders. Why to use placebo The use of placebo in this study is justified due to the facts: Symptoms of functional dyspepsia have a high rate of improvement with placebo. Comparative studies with some drugs show that the placebo effect is up to the order of 30 to 40%. can not rule out the placebo effect, if the magnitude of this drug therapies are not compared to placebo. Justification of the study This study is justified for several reasons, but mainly by the limitations of the biomedical model. The changes in the epidemiological profile (which has been occurring in recent decades) are increasingly leaving very clear the role of psychological, socio-cultural and spiritual factors, as expressed by the personality and lifestyle. The same biomedicine with its progress and sophistication is showing its inability to provide satisfactory or conclusive answers to many problems, especially for the subjective components that come into greater or lesser degree in any disease. Biomedicine is too limited in its explanatory power. Many medical professionals realize the psychological reactions of patients and their socioeconomic problems involved in the disease but do not see how to incorporate this information in formulating diagnosis and treatment decisions. The idea of ilness as a phenomenon more or less accidental, originating in the biochemical processes of the body is very restricted, and therefore produces restricted results too.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
biopsychosocial model, biomedical model, functional dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A2- Medical consultation + placebo
Arm Type
Placebo Comparator
Arm Description
Traditional medical interview + placebo
Arm Title
B1 - Therapeutic Encounter / Omeprazol
Arm Type
Active Comparator
Arm Title
B2 - Therapeutic Encounter / Placebo
Arm Type
Placebo Comparator
Arm Title
A1- Medical consultation + omeprazole
Arm Type
Active Comparator
Arm Description
Traditional medical interview + omeprazole
Intervention Type
Procedure
Intervention Name(s)
Traditional Medical Consultation
Intervention Description
Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Encounter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.
Time Frame
between four to six months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando S Guedes, Master
Phone
5511-7760-4287
Email
amarelodosol@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Wilson R Catapani, Doctoral
Phone
5511-49935416
Email
w.gastro@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando S Guedes, Master
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando S Guedes, Master
Phone
5511-7760-4287
Email
amarelodosol@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Wilson R Catapani, Doctor
Phone
5511-4993-5416
Email
w.gastro@terra.com.br
First Name & Middle Initial & Last Name & Degree
Fernando S Guedes, Master
First Name & Middle Initial & Last Name & Degree
Wilson R Catapani, Doctor

12. IPD Sharing Statement

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

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