Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
Hellerup, DK-2900, Denmark
NCT Number: NCT02586545
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hellerup, DK-2900, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and follow-up at 12, 24 and 36 months
Time frame: Follow-up at 12, 24 and 36 months after baseline
These indicators cover seven areas: HbA1c, blood pressure, low density lipoprotein, albuminuria, fundoscopy, foot examination and smoking status.
Time frame: Baseline and follow-up at 12, 24 and 36 months
Measured by the Short Form 36 (SF-36)
Time frame: Baseline and follow-up at 12, 24 and 36 months
Time frame: Baseline and follow-up at 12, 24 and 36 months
Meassured by the Diabetes Symptom Checklist-revised (DSC-r).
University Hospital, Gentofte, Copenhagen
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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