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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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR915 |
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Date of registration:
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20/02/2007 |
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Primary sponsor: |
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Public title:
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Diabetes Care Implementation Study.
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Scientific title:
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Diabetes Care Implementation Study. - DIS |
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Date of first enrolment:
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1/3/2004 |
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Target sample size:
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3500 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=915 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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F.G.W.
Cleveringa |
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Address:
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University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care, Stratenum 6.131
P.O. Box 85500
3500 GA
Utrecht
The Netherlands |
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Telephone:
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+31 30-2538608 |
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Email:
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f.g.w.cleveringa@umcutrecht.nl |
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Affiliation:
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Name:
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F.G.W.
Cleveringa |
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Address:
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University Medical Center Utrecht
Julius Center for Health Sciences and Primary Care, Stratenum 6.131
P.O. Box 85500
3500 GA
Utrecht
The Netherlands |
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Telephone:
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+31 30-2538608 |
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Email:
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f.g.w.cleveringa@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Diabetes mellitus type 2.
Exclusion criteria: 1. Under treatment of medical specialist;
2. Terminally ill patients;
3. Patients with complex multi morbidity;
4. Patients not able to visit the general practice.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus type 2 (DM type II), Primary care, Decision Support System (Clinical), Quality of Health Care
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Intervention(s)
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Implementing the diabetes care protocol (DCP) developed by Diagnosis 4 Health.
Characteristics: consultationhour exclusively scheduled for DM2 patients and delegation of routine diabetes care tasks to a trained practice nurse who uses the DCP software that supports management and medical decisions.
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Primary Outcome(s)
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1. Change in:
a. HbA1c%;
b. Blood pressure;
c. Total cholesterol.
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Secondary Outcome(s)
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1. Change in cardiovascular risk;
2. Effects on quality of life and patient treatment satisfaction;
3. Effects on proces of care.
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Secondary ID(s)
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ISRCTN21523044
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Source(s) of Monetary Support
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University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
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