Shared Care for Patients With Type 2 Diabetes Across the Primary and Secondary Health Care Sector
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Shared care (Other)
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.
结局指标
主要结局
Change from baseline Hemoglobin A, Glycosylated (HbA1c) at 12, 24 and 36 months
时间窗: Baseline and follow-up at 12, 24 and 36 months
次要结局
- The proportion of patients who meet national standard indicators reflecting quality of care(Follow-up at 12, 24 and 36 months after baseline)
研究者
Lene Munch
MHS, Ph.D.-student
University Hospital, Gentofte, Copenhagen