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.
Descripción general del estudio
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Hellerup, Dinamarca, DK-2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The proportion of patients who meet national standard indicators reflecting quality of care
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline Quality of life at 12, 24 and 36 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lene Munch, MHS, Ph.D.-student, Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DIA-1234
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