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Diabetes care Implementation Study
ISRCTN ISRCTN21523044
DOI 10.1186/ISRCTN21523044
ClinicalTrials.gov identifier
EudraCT number
Public title Diabetes care Implementation Study
Scientific title
Acronym DIS
Serial number at source N/A
Study hypothesis Diabetes care can be improved by task delegation to a practice nurse supported by computerised decision support and benchmarking.
Lay summary
Ethics approval Received from the local ethics committee (Medical Ethics Committee, UMC-Utrecht) on the 24th February 2004 (ref: 03/233-E).
Study design Randomised, active controlled, parallel group, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Diabetes Mellitus type two (DM2)
Participants - inclusion criteria Diabetes Mellitus type two (DM2)
Participants - 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
Anticipated start date 01/03/2004
Anticipated end date 30/05/2007
Status of trial Completed
Patient information material
Target number of participants 3500
Interventions Implementing the Diabetes Care Protocol (DCP) developed by Diagnosis 4 Health.

Characteristics: consultation hour 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.
Primary outcome measure(s) 1. Change in:
a. HbA1c %
b. Blood pressure
c. Total cholesterol

The primary and secondary outcomes will all be measured at baseline and after one year follow-up.
Secondary outcome measure(s) 1. Change in cardiovascular risk
2. Effects on quality of life and patient treatment satisfaction
3. Effects on process of care

The primary and secondary outcomes will all be measured at baseline and after one year follow-up.
Sources of funding University Medical Centre Utrecht (UMCU) (The Netherlands)
Trial website
Publications
Contact name Dr  F.G.W.  Cleveringa
  Address University Medical Centre Utrecht
Julius Centre for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3500 GA
  Country Netherlands
  Tel +31 (0)30 253 8608
  Email f.g.w.cleveringa@umcutrecht.nl
Sponsor University Medical Centre Utrecht (UMCU) (The Netherlands)
  Address Julius Center for Health Sciences and Primary Care
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508 GA
  Country Netherlands
  Tel +31 (0)30 250 9358
  Fax +31 (0)30 505 480
  Email juliuscenter@azu.nl
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 02/05/2007
Last edited 14/06/2007
Date ISRCTN assigned 02/05/2007
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