Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-88jb56 |
Date of registration:
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26/01/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Interventions to hypertension control
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Scientific title:
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Factors associated with no control of hypertension and effectiveness of individual interventions and group for the promotion of disease control |
Date of first enrolment:
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10/01/2016 |
Target sample size:
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Recruitment status: |
Recruiting |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-88jb56 |
Study type:
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Intervention |
Study design:
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Clinical trial, paralel, with three arms, open, randomized control, prospective.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Adriane Isabel
Rohden |
Address:
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Sarmento Leite, 245
90050-170
Porto Alegre
Brazil |
Telephone:
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+55 (51) 9857 5662 |
Email:
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adrianeisabel@gmail.com |
Affiliation:
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Universidade Federal de Ciências da Saúde de Porto Alegre |
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Name:
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Carine Raquel
Blatt |
Address:
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Sarmento Leite, 245
90050-170
Porto Alegre
Brazil |
Telephone:
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+55 (51) 9833 8000 |
Email:
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carine.blatt@gmail.com |
Affiliation:
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Universidade Federal de Ciências da Saúde de Porto Alegre |
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Key inclusion & exclusion criteria
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Inclusion criteria: Hypertension patients with more than 18 years old and uncontroll hypertension (blood pression rate more that 140/90 mmHg) and participed of transversal study.
Exclusion criteria: Patients with secundary hypertension. Institutionalized patients, with mental illness or disabling chronic illness or a life expectancy of less than one year.
Age minimum:
18Y
Age maximum:
90Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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N04.452.758.244
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Behavioural
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F02.784.176.279.500
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Patients without hypertension control will be aleatorized randomized into three groups of 130 patients to receive three interventions: individual counseling (CONSULTA), group monitoring (GROUP) and control (CONTROL). Patients included in the GROUP will have meetings biweekly during three months, with predefined themes as the needs of patients. These groups will last for a minimum 1 hour and maximum of 3 hours and will have a maximum of 20 participants. Patients included in the CONSULTA will be done monthly consultation with a time of 15-60 min for three months, performed by students (pharmacy, psychology, nursing, medicines and nutrition) under supervision of an assistent professor. Patients included in the CONTROL will have usual follow up and blood pressure mesure after 4 months.
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Primary Outcome(s)
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Mean reduction of blood pressure in mmHg calculated by Systolic and Diastolic Blood Pressure mean comparing between baseline time and endpoint.
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Secondary Outcome(s)
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Treatment Adherence evaluated by Morisky Green scale at the baseline and endpoint.
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
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Universidade Federal de Ciências da Saúde de Porto Alegre
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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