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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR833 |
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Date of registration:
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08/12/2006 |
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Primary sponsor: |
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Public title:
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Cost-effectiveness of care for patients with type 2 diabetes, an evaluation of an innovative shared diabetes care model.
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Scientific title:
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Cost-effectiveness of care for patients with type 2 diabetes, an evaluation of an innovative shared diabetes care model. - N/A |
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Date of first enrolment:
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1/3/2007 |
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Target sample size:
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1200 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=833 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: [default]
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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A.
Heijden, van der |
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Address:
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Emgo-Instituut
Van der Boechorststraat 7
1081 BT
Amsterdam
The Netherlands |
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Telephone:
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+31 20-4448409 |
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Email:
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A.vanderHeijden@vumc.nl |
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Affiliation:
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Name:
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A.
Heijden, van der |
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Address:
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Emgo-Instituut
Van der Boechorststraat 7
1081 BT
Amsterdam
The Netherlands |
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Telephone:
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+31 20-4448409 |
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Email:
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A.vanderHeijden@vumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with type 2 diabetes;
2. Age 40-75 years;
3. Written informed consent;
4. Capable to fill in questionnaires;
5. Understanding of Dutch language.
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 GP.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus type 2 (DM type II)
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Intervention(s)
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Intervention I:
A shared care model will be implemented in Amstelland in cooperation with the organisations involved with local diabetes care: VUmc, Amsterdam Homecare Organisation, Amsterdam doctors laboratory (ATAL) and local general practitioners as part of the CBO. The implemented diabetes care consists of structured care achieved by the use of a central database, a coordinating role for the diabetes nurse and an active recall system. An annual diabetes check is offered to patients in combination with patient education by a diabetes nurse and a consultation with a dietician. A diabetes nurse will support diabetes care in general practice.
Intervention II:
In addition to the evaluation of the implementation of the structured diabetes care in Amstelland, we will investigate the structured diabetes care as it is successfully implemented in West-Friesland. In West-Friesland, patients receive care by the diabetes care system (DCS) in addition to the care delivered by their own GP. The DCS coordinates regional diabetes care using a centrally organized database that is available to all involved caregivers. Diabetes nurses and dieticians perform an annual follow-up examination of individual patients to assess glucose control, cardiovascular disease risk profile, and the presence of complications, and coordinate the care among different healthcare providers, including GPs, specialists, and podotherapists. The diabetes nurses visit the GPs every 6 months to compare mean risk factor levels of the patients in that GP's practice with mean levels from all GPs, and to discuss results for individual patients. The diabetes nurses also provide specific therapeutic advice for the GPs to implement. Patient empowerment in the DCS consists of 3 elements in order to improve patient self-management: providing education; supplying information; and promoting self-monitoring of blood glucose.
Controlgroup:
The control group consists of patients of GP's who are affiliated
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Primary Outcome(s)
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1. The risk of developing coronary heart disease (using the UKPDS risk engine at baseline, 2 yrs before and year 1 and 2 after baseline);
2. All direct and indirect costs (cost diary); 3. Costs per lifeyear gained.
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Secondary Outcome(s)
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1. Absolute levels of fasting glucose;
2. HbA1c level;
3. Blood pressure;
4. Cholesterol;
5. Percentages adequately controlled patients (in accordance with the 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; Percentage of patients that received all 3-monthly check-ups, a complete annual check-up, were hospitalized;
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. QALY?s 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.
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Secondary ID(s)
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ISRCTN66124817
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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