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.
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Hellerup, Danimarca, DK-2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
Lasso di tempo: Baseline and follow-up at 12, 24 and 36 months
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Baseline and follow-up at 12, 24 and 36 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The proportion of patients who meet national standard indicators reflecting quality of care
Lasso di tempo: Follow-up at 12, 24 and 36 months after baseline
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These indicators cover seven areas: HbA1c, blood pressure, low density lipoprotein, albuminuria, fundoscopy, foot examination and smoking status.
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Follow-up at 12, 24 and 36 months after baseline
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline Quality of life at 12, 24 and 36 months
Lasso di tempo: Baseline and follow-up at 12, 24 and 36 months
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Measured by the Short Form 36 (SF-36)
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Baseline and follow-up at 12, 24 and 36 months
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Change from baseline blood pressure at 12, 24 and 36 months
Lasso di tempo: Baseline and follow-up at 12, 24 and 36 months
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Baseline and follow-up at 12, 24 and 36 months
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Change from baseline diabetes symptoms at 12, 24 and 36 months
Lasso di tempo: Baseline and follow-up at 12, 24 and 36 months
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Meassured by the Diabetes Symptom Checklist-revised (DSC-r).
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Baseline and follow-up at 12, 24 and 36 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Lene Munch, MHS, Ph.D.-student, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DIA-1234
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