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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hellerup、丹麦、DK-2900
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The proportion of patients who meet national standard indicators reflecting quality of care
大体时间：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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline Quality of life at 12, 24 and 36 months
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Lene Munch, MHS, Ph.D.-student、Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Denmark. Institute of Nursing, University College Metropol, Denmark.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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