Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
30/06/2014
Prospective/Retrospective
Prospectively 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 A van der Heijden

ORCID ID

Contact details

Emgo-Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8409
A.vanderHeijden@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The intervention will primarily affect the level of patient control with regard to glycemia, lipid levels and blood pressure. We will expect a substantial decline in the occurrence and severity of complications and mortality and an improved quality of life. The innovative shared diabetes care is expected to be more cost-effective than the usual diabetes care.

Ethics approval

Not provided at time of registration

Study design

A quasi-experimental pre-test-post-test control group design

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Diabetes Mellitus type two (DM type II)

Intervention

An innovative shared diabetes care model ('ketenzorgmodel') will be implemented in general practices in Amstelland. The 'ketenzorgmodel' will be implemented with a central organisation of the diabetes care with a central database, a central coordinating role for diabetes nurses (changed professional roles), and an active recall system. The annual diabetes check is offered to patients by the central organisation, in combination with patient education, by a diabetes nurse and a consultation with a dietician. In addition, structured education will be offered to general practitioners and their assistants, and a diabetes nurse will support diabetes care in general practice.

Diabetes patients in the control group will receive the current usual diabetes care. The control group will consist of patients of GP's who are affiliated to the Netherlands Institute for Health Services Research (NIVEL) Continuous Morbidity Registration Centres (CMR sentinel stations [CMR-Peilstations]). NIVELs 'CMR-Peilstations' consitute a representative group of 60 Dutch GPs in 45 practices throughout the Netherlands.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The risk of developing coronary heart disease (using the United Kingdom Prospective Diabetes Study [UKPDS] risk engine at baseline, two years before and year one and two after baseline)
2. All direct and indirect costs (cost diary)
3. Costs per life year gained

Secondary outcome measures

1. Absolute levels of fasting glucose
2. HbA1c level
3. Blood pressure
4. Cholesterol
5. Percentages adequately controlled patients (in accordance with the Dutch College of Family Physicians [NHG] standards)
6. Diabetes specific and generic quality of life
7. Patient satisfaction
8. Quality of life
9. Quality of care as experienced by the patient:
a. percentage of patients that received all three-monthly check-ups
b. a complete annual check-up
c. were hospitalised
10. Total mortality measured by life expectancy
11. Total morbidity measured by morbidity-free life expectancy and the Net Present Value (NPV) of the number of life years gained
12. Quality Adjusted Life Years (QALYs) gained for the intervention scenario compared to the current practice scenario
13.The NPV of total intervention costs
14. The NPV of total costs of care for diabetes and its complications
15. Incremental costs per QALY gained

Overall trial start date

01/03/2007

Overall trial end date

01/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with type two diabetes
2. Age 40 to 75 years
3. Written informed consent
4. Capable to fill in questionnaires
5. Understanding of Dutch language

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients will be excluded for participation in this study if no beneficial effects can be expected in favour of the patient, according to the opinion of the General Practitioner (GP).

Recruitment start date

01/03/2007

Recruitment end date

01/01/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Emgo-Instituut
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/english/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24966055

Publication citations

  1. Results

    van der Heijden AA, de Bruijne MC, Feenstra TL, Dekker JM, Baan CA, Bosmans JE, Bot SD, Donker GA, Nijpels G, Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial., BMC Health Serv Res, 2014, 14, 280, doi: 10.1186/1472-6963-14-280.

Additional files

Editorial Notes