From the Biomedical to the Biopsychosocial Model, From Theory to Practice
Evaluation of the Efficacy of the Integral Approach (Therapeutic Encounter) Versus the Conventional Medical Approach (Medical Consultation) in Patients With Functional Dyspepsia
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedOctober 20, 2011
October 1, 2011
2.8 years
August 23, 2011
October 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of dyspeptic symptoms questionnaire administered at the beginning and end of treatment.
between four to six months of treatment
Study Arms (4)
A2- Medical consultation + placebo
PLACEBO COMPARATORTraditional medical interview + placebo
B1 - Therapeutic Encounter / Omeprazol
ACTIVE COMPARATORB2 - Therapeutic Encounter / Placebo
PLACEBO COMPARATORA1- Medical consultation + omeprazole
ACTIVE COMPARATORTraditional medical interview + omeprazole
Interventions
Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando S Guedes, Master
Faculdade de Medicina do ABC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2011
First Posted
October 20, 2011
Study Start
March 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
October 20, 2011
Record last verified: 2011-10