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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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201302000478315 |
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Date of registration:
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01/01/2013 |
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Primary sponsor: |
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Public title:
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A RANDOMISED CONTROL TRIAL COMPARING INTENSIVE WITH CONVENTIONAL EDUCATION FOR DIABETES MELLITUS PATIENTS IN CALABAR
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Scientific title:
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A RANDOMISED CONTROL TRIAL COMPARING INTENSIVE WITH CONVENTIONAL EDUCATION FOR DIABETES MELLITUS PATIENTS IN CALABAR |
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Date of first enrolment:
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2012-06-01 |
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Target sample size:
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100 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201302000478315 |
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Study type:
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interventional |
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Study design:
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Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
Simple randomisation using a randomisation table from a statistics book,
Allocation was determined by the holder of the sequence who is situated off site,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Victor
Umoh |
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Address:
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University of Calabar Teaching Hospital
PMB 1278
Calabar
Nigeria |
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Telephone:
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+2348055026582 |
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Email:
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aaumoh@gmail.com |
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Affiliation:
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Consultant Physician |
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Name:
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Akaninyene
Otu |
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Address:
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University of Calabar Teaching Hospital
PMB 1278
Calabar
Nigeria |
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Telephone:
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+2348105723133 |
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Email:
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akanotu@yahoo.com |
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Affiliation:
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Consultant Physician |
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Key inclusion & exclusion criteria
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Inclusion criteria: ? HBA1c b 8.5 % measured before randomization.
? Age b 18 years.
? Able to exercise.
? Available to participate if randomized in the program.
? Provision of written informed consent.
Exclusion criteria: ? Significant eye disease limiting visual acuity.
? Lower extremity amputation limiting exercise.
? No written informed consent.
Age minimum:
18 Year
Age maximum:
100 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus
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Primary Outcome(s)
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significant reduction in HbA1c after 6 months of intensive education
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Secondary ID(s)
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nil known
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Source(s) of Monetary Support
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Self funded
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