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| Name | Class |
|---|---|
| Metropolitan University College | OTHER |
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The aim of the study is to test the effect of a new shared care model for type 2 diabetes care and compare it with a standardized care management program in a specialized hospital-based out-patient clinic.
The hypothesis is that participants with type 2 diabetes followed in a shared care program will have a comparable outcome in HbA1c to participants receiving standard care.
The prevalence of patients with type 2 diabetes is in growth globally. In order to secure high quality in diabetes care it is necessary to rethink the way in which the care is organized. The investigators want to test a new model of shared care across the interface of primary and secondary care sector for patients with type 2 diabetes who are at risk stratification level 2. Based on a national and regional risk stratification model patients can be stratified to three levels according to risk and complexity of treatment: level 1 (uncomplicated), level 2 (intermediate risk) and level 3 (high risk).
The objective of the study is to show equal outcomes among the participants being treated in either a shared care program or an established program in a specialized outpatient clinic.
The study is a non-inferiority randomized controlled trial. The shared care model will be tested during a period of three years. All participants are offered four medical visits a year. The shared care intervention consists of one annual comprehensive check-up at the outpatient clinic and three quarterly visits at a general practice. The control group is followed with four quarterly visits at the outpatient clinic including an annual comprehensive check-up. The recruitment period spans over approximately 12 months, and participants are randomized to intervention or control group in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared care model | Experimental | Four visits a year: one annual comprehensive check-up at the outpatient diabetes clinic and three quarterly visits at the general practitioner. |
|
| Mono sectorial care | No Intervention | Treament as usual including four visits a year with the diabetes team at the outpatient clinic: an annual comprehensive check-up, identical to the one received by the intervention group, and three quarterly visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared care | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months | Baseline and follow-up at 12, 24 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who meet national standard indicators reflecting quality of care | These indicators cover seven areas: HbA1c, blood pressure, low density lipoprotein, albuminuria, fundoscopy, foot examination and smoking status. | Follow-up at 12, 24 and 36 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Quality of life at 12, 24 and 36 months | Measured by the Short Form 36 (SF-36) | Baseline and follow-up at 12, 24 and 36 months |
| Change from baseline blood pressure at 12, 24 and 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lene Munch, MHS, Ph.D.-student | Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Diabetes Research, Gentofte Hospital, University of Copenhagen | Hellerup | DK-2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27259669 | Derived | Munch L, Bennich B, Arreskov AB, Overgaard D, Konradsen H, Knop FK, Vilsboll T, Roder ME. Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial. Trials. 2016 Jun 4;17(1):277. doi: 10.1186/s13063-016-1409-y. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline and follow-up at 12, 24 and 36 months |
| Change from baseline diabetes symptoms at 12, 24 and 36 months | Meassured by the Diabetes Symptom Checklist-revised (DSC-r). | Baseline and follow-up at 12, 24 and 36 months |
| D004700 | Endocrine System Diseases |