Cost-effectiveness of care for patients with type two diabetes: an evaluation of an innovative shared diabetes care model
| ISRCTN | ISRCTN66124817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66124817 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 30/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A van der Heijden
Scientific
Scientific
Emgo-Instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8409 |
|---|---|
| A.vanderHeijden@vumc.nl |
Study information
| Study design | A quasi-experimental pre-test-post-test control group design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2007 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key 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). |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Emgo-Instituut
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Sponsor information
VU University Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8180 |
|---|---|
| emgo@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/06/2014 | Yes | No |
