Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERShared care
Sponsors
Metropolitan University College
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be over the age of 18 years * The diagnosis of type 2 diabetes * Risk stratification level 2 * Capable of speaking and writing in Danish * Give oral and written consent before entering the study
Exclusion criteria
* Diagnosed with other types of diabetes than type 2 diabetes * Risk stratification level 1 or 3 * Being pregnant or breastfeeding * Having severe co-morbidity with life expectancy less than five years * Being under such conditions, that the patient will not be able to show up or go through with the appointments (e.g. moderate to severe dementia and severe psychiatric conditions) * Participating in long-lasting interventions (\>2 weeks) that potentially affects the primary outcome in our study or patients participating in studies which include blood sampling amounting to \>5 % of the blood volume two months prior to the randomisation and/or the follow-up visits
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who meet national standard indicators reflecting quality of care | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Quality of life at 12, 24 and 36 months | Baseline and follow-up at 12, 24 and 36 months | Measured by the Short Form 36 (SF-36) |
| Change from baseline blood pressure at 12, 24 and 36 months | Baseline and follow-up at 12, 24 and 36 months | — |
| Change from baseline diabetes symptoms at 12, 24 and 36 months | Baseline and follow-up at 12, 24 and 36 months | Meassured by the Diabetes Symptom Checklist-revised (DSC-r). |
Countries
Denmark
Outcome results
None listed