Contact information
Type
Scientific
Primary contact
Dr F.G.W. Cleveringa
ORCID ID
Contact details
University Medical Centre Utrecht
Julius Centre for Health Sciences and Primary Care
Stratenum 6.131
P.O. Box 85500
Utrecht
3500 GA
Netherlands
+31 (0)30 253 8608
f.g.w.cleveringa@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DIS
Study hypothesis
Diabetes care can be improved by task delegation to a practice nurse supported by computerised decision support and benchmarking.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Diabetes Mellitus type two (DM2)
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/03/2004
Overall trial end date
30/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diabetes Mellitus type two (DM2)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
3500
Participant 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
Recruitment start date
01/03/2004
Recruitment end date
30/05/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht
Utrecht
3500 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (The Netherlands)
Sponsor details
Julius Center for Health Sciences and Primary Care
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 9358
juliuscenter@azu.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Centre Utrecht (UMCU) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list