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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24966055
Publication citations
-
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.