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Functional DyspepsiaNCT01456273

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

A study testing Traditional Medical Consultation and Therapeutic Encounter in people with Functional Dyspepsia, run by Faculdade de Medicina do ABC at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Functional Dyspepsia
What is being tested?
Traditional Medical Consultation and Therapeutic Encounter
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteBrazil
Study dates
Mar 2009to Dec 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Fernando S Guedes, Master contact

5511-7760-4287

amarelodosol@yahoo.com.br

Wilson R Catapani, Doctoral contact

5511-49935416

w.gastro@terra.com.br

Brazil1 site, 1 recruiting
  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-870

    Fernando S Guedes, Master, 5511-7760-4287, amarelodosol@yahoo.com.br

    Wilson R Catapani, Doctor, 5511-4993-5416, w.gastro@terra.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia

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).

Read the 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.

Being tested
Traditional Medical Consultation, Therapeutic Encounter
Keywords
biopsychosocial model, biomedical model, functional dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Medical ConsultationProcedure or surgery

    Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole

  • Therapeutic EncounterProcedure or surgery

    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.

Study groups in NCT01456273
Study groupRoleWhat they receive
A2- Medical consultation + placeboPlacebo comparatorTraditional medical interview + placebo
Receives: Procedure: Traditional Medical Consultation
B1 - Therapeutic Encounter / OmeprazolActive comparatorNot described
Receives: Procedure: Therapeutic Encounter
B2 - Therapeutic Encounter / PlaceboPlacebo comparatorNot described
Receives: Procedure: Therapeutic Encounter
A1- Medical consultation + omeprazoleActive comparatorTraditional medical interview + omeprazole
Receives: Procedure: Traditional Medical Consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: between four to six months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2011 (estimated)
  2. Study startMar 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01456273
Sponsor's protocol ID
Guedes, FG 01
Status last verified
Oct 2011
First submitted
23 Aug 2011
Last updated
20 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Traditional Medical Consultation and Therapeutic Encounter in people with Functional Dyspepsia, run by Faculdade de Medicina do ABC at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fernando S Guedes, Master (5511-7760-4287, amarelodosol@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment. (time frame: between four to six months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.

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