The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes (CADS)
2015年11月24日 更新者：Alicia L. Warnock、Walter Reed National Military Medical Center
The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1c, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
研究概览
详细说明
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g.
A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses.
The software makes a recommendation about what medication changes are appropriate with potential alternates.
Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
研究类型
介入性
注册 (实际的)
28
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
-
Bethesda、Maryland、美国、20889
- Walter Reed National Military Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
- Absence of orders for deployment or permanent change of station
- Willingness to recruit up to 19 patients prior to randomization
- Willingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
Exclusion Criteria:
- Specialist physicians
- Orders for deployment or permanent change of station
- Unwillingness to recruit up to 19 patients prior to randomization
- No prior experience with management of type 2 diabetes in adults
- Unwillingness to deliver "usual care" as defined in Section 6.3.2 of the protocol.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Computer-Assisted Decision Support
These providers will use the CADS program to treat their enrolled patients.
|
The CADS software makes a recommendation about what medication changes are appropriate with potential alternates.
CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month.
They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit.
Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.
|
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 A1c
大体时间：baseline, 12, 24, 36, and 48 months
|
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
|
baseline, 12, 24, 36, and 48 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Major events
大体时间：ongoing
|
The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
|
ongoing
|
|
Other DM-related events
大体时间：ongoing
|
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
|
ongoing
|
|
Glucose measures
大体时间：baseline, 12, 24, 36, 48 months
|
Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
|
baseline, 12, 24, 36, 48 months
|
|
Blood pressure
大体时间：baseline, 12, 24, 36, and 48 months
|
Clinically significant or statistically detectable changes in BP
|
baseline, 12, 24, 36, and 48 months
|
|
Lipids
大体时间：baseline, 12, 24, 36, and 48 months
|
Clinically significant or statistically detectable changes in lipid profile.
|
baseline, 12, 24, 36, and 48 months
|
|
Patient satisfaction with treatment
大体时间：basline and 48 months
|
Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
|
basline and 48 months
|
|
Quality of life
大体时间：baseline and 48 months
|
Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
|
baseline and 48 months
|
|
Degree of Acceptance
大体时间：baseline and 48 months
|
The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
|
baseline and 48 months
|
|
Acceptance of uploading data
大体时间：baseline, 12, 24, 36, and 48 months
|
The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
|
baseline, 12, 24, 36, and 48 months
|
|
Demographic variables
大体时间：baseline and 48 months
|
The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
|
baseline and 48 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Robert A Vigersky, M.D.、Walter Reed National Military Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年3月1日
初级完成 (实际的)
2015年3月1日
研究完成 (实际的)
2015年3月1日
研究注册日期
首次提交
2012年7月17日
首先提交符合 QC 标准的
2012年7月19日
首次发布 (估计)
2012年7月24日
研究记录更新
最后更新发布 (估计)
2015年11月25日
上次提交的符合 QC 标准的更新
2015年11月24日
最后验证
2015年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.