Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.
Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.
研究概览
详细说明
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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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Health System
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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:
- Men or women aged ≥18 years of age;
- Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- Treated with insulin or at least two diabetes medications;
- Have A1C ≥8.0% and ≤11.0%;
- Able and willing to use telephone or other sorts of communication regularly between clinic visits.
Exclusion Criteria:
- Do not speak English;
- Unwilling or unable to provide informed consent;
- Have any condition associated with life expectancy of less than 3 years;
- Have an active mental illness or substance abuse
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:Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
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Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
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有源比较器:Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
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Diabetes and comorbidities management will provided by an endocrinologist
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in baseline A1C (glycated hemoglobin) at 12 months
大体时间:12 months
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Measure of long-term blood glucose control and efficacy of intervention
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in baseline lipids at 12 months
大体时间:12 months
|
Measure of total cholesterol, LDL, and Triglycerides
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12 months
|
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Change in baseline blood pressure at 12 months
大体时间:12 months
|
Systolic and diastolic blood pressure
|
12 months
|
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All cause mortality
大体时间:12 months
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Record deaths due to any cause
|
12 months
|
|
Acute complications
大体时间:12 months
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Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
|
12 months
|
|
Change in baseline Quality of life at 12 months
大体时间:12 months
|
Short Form-36
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12 months
|
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Change in baseline insulin satisfaction at 12 months
大体时间:12 months
|
Insulin Therapy Satisfaction Questionnaire
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12 months
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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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Clinic retention
大体时间:12 months
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Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
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12 months
|
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Cost
大体时间:12 months
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Resource utilization and cost for both groups
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12 months
|
合作者和调查者
调查人员
- 首席研究员:Israel Hodish, MD, PhD、University of Michigan
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
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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