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Main
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Note: This record shows only the 20 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. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-6twwh2 |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Nursing consultation in the monitoring of adults with type 2 diabetes.
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Scientific title:
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Effect of using the method of case management on glycemic control in people with type 2 diabetes. |
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Date of first enrolment:
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12/07/2011 |
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Target sample size:
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80 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6twwh2/ |
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Study type:
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Study design:
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Clinical trial, randomized controlled, open, with two arms.
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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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Ricardo
Moreira |
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Address:
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Av. Minas Gerais, 655. Ed. Marajó. Apto. 62.
86300-000
Cornélio Procópio
Brazil |
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Telephone:
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(43)9964-0974 |
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Email:
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ricardocastanho@uenp.edu.br |
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Affiliation:
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Universidade Federal do Paraná |
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Name:
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Maria
Mantovani |
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Address:
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Av. Pref. Lothário Meissner, 632. 3 Andar. Jardim Botânico.
80210-170
Curitiba
Brazil |
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Telephone:
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(41) 85027840 |
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Email:
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mfatimamantovani@ufpr.br |
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Affiliation:
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Universidade Federal do Paraná |
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Key inclusion & exclusion criteria
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Inclusion criteria: Being patient with type 2 diabetes mellitus;
Both sexes;
Age between 18 and 60 years;
Accept the invitation to participate in the survey;
Being a resident of Bandeirantes city.
Exclusion criteria: People with type 2 diabetes who have psychiatric disorders, which affect the language;
People with type 1 diabetes;
Pregnant women;
Persons who plan to move to another neighborhood that has not attended for the UBS-ESF or PACS, or even moving to another city.
Age minimum:
18Y
Age maximum:
59Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Diabetes mellitus type 2.
C18.452.394.750.149
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Intervention(s)
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Participants in the intervention group will receive usual care in primary health care and family will be accompanied by the method of case management for 12 months, which include nursing visits bimonthly, monthly telephone monitoring, home visits monthly, bimonthly group educational activities and consultation with multidisciplinary team as needed (pharmacists, nutritionists, primary care physicians and nephrologists).
Participants in the control group will receive usual care in primary health care and family nursing visits bimonthly, bimonthly group educational activities and consultation with multidisciplinary team as needed (pharmacists, nutritionists, primary care physicians and nephrologists).
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Primary Outcome(s)
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Glycemic control, assessed by capillary blood glucose below 110 mg / dL, fasting plasma glucose below 110 mg / dL and glycated hemoglobin less than 7%.
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Secondary Outcome(s)
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Risk factors for chronic complications. Will be used to classify the degree of risk for diabetic foot proposed by the Ministry of Health and Cockrof-Gault formula to assess glomerular filtration rate. And adherence to drug therapy
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Secondary ID(s)
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CAAE 0043.0.091.091-11
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Source(s) of Monetary Support
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Secretaria Municipal de Saúde de Bandeirantes. - Brazil
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Fundação ARAUCÁRIA - Brazil
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