Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Hellerup, Danmark, DK-2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Shared care model
Four visits a year: one annual comprehensive check-up at the outpatient diabetes clinic and three quarterly visits at the general practitioner.
|
|
|
Inget ingripande: Mono sectorial care
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
Tidsram: Baseline and follow-up at 12, 24 and 36 months
|
Baseline and follow-up at 12, 24 and 36 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The proportion of patients who meet national standard indicators reflecting quality of care
Tidsram: 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.
|
Follow-up at 12, 24 and 36 months after baseline
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline Quality of life at 12, 24 and 36 months
Tidsram: Baseline and follow-up 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
Tidsram: Baseline and follow-up 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
Tidsram: Baseline and follow-up 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Lene Munch, MHS, Ph.D.-student, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DIA-1234
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .