Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
14/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.umcutrecht.nl/zorg/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes