Coordinating Pragmatic Primary Care Population Management for Obesity (C3PO)
2022年1月28日 更新者：Ronald Ackermann、Northwestern University
The C3PO pilot and feasibility study uses a rigorous, mixed-method research design to provide information needed to refine and implement a technology-mediated primary care outreach intervention approach before conducting a larger and more definitive future intervention trial.
研究概览
地位
完全的
详细说明
This study will implement and evaluate a pragmatic and generalizable framework for population management of obesity by the primary care sector.
With patient and other stakeholder input, the C3PO intervention will be designed to leverage existing primary care professionals and technologies to implement a scalable framework for population obesity management that coordinates primary care services with extant intensive lifestyle interventions in community settings to achieve wider reach and population-level effectiveness.
A rigorous, mixed-method pilot and feasibility study will provide critical information needed to optimize the intervention design and prepare us for a larger and definitive future trial.
研究类型
介入性
注册 (实际的)
80
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
-
-
Illinois
-
Chicago、Illinois、美国、60611
- Northwestern Medicine
-
-
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
18年 及以上 (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:
- BMI ≥ 27 kg/m2
- ≥ 1 CVD risk condition (hypertension, dyslipidemia, prediabetes or type 2 diabetes)
- Registered in Northwestern Medical Group's EpicCare MyChart patient portal
- Received and completed MyChart survey of weight loss interest
- Affirms interest in weight loss goal setting and receiving additional resource information and electronic Scale.
Exclusion Criteria:
- Evidence of hospitalization in past 30 days
- Most recent blood pressure >180/105
- Cancer (non-skin) treatment within the past 2 years
- Encounter diagnosis for hypoglycemia in past 30 days
- Actively receiving care from the bariatric surgery service or a bariatric medication order in the past 100 days
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：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Basic Resources and Services
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, and information about linkages to extant intensive lifestyle interventions in the community
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
|
|
实验性的：Coordinated Primary Care Population Management (C3PO)
Patients will receive outreach engagement in goal setting via MyChart, an electronic scale, telemonitoring of self weighing, information about linkages to extant intensive lifestyle interventions, and outreach MyChart messages that are tailored to each individual's pattern of self-weighing and progress towards their weight goal, and more intensive support from a primary care nurse based on self-weighing behavior and weight loss success.
|
Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning.
Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community.
Patients who request information or clinical referrals will also receive them.
"Refreshes" of community linkage information will be sent by MyChart every 1 to 4 weeks.
Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal.
Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team.
Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
|
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 |
|---|---|---|
|
Number of Participants Who Achieved 5% Weight Loss Goal at 6 Months
大体时间：Baseline - 6 Months
|
Proportion of Participants who Reach a 5% Weight Loss Goal at 6 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 6 months (kg))/(Baseline body mass (kg))
|
Baseline - 6 Months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Costs to Implement the Intervention
大体时间：Baseline - 12 Months
|
Costs (US$) of Intervention Components, including the costs to fund personnel efforts, technology, and other intervention components
|
Baseline - 12 Months
|
|
Change in Hemoglobin A1C
大体时间：Baseline - 12 Months
|
Mean change in Hemoglobin A1C levels (DCCT%) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Systolic Blood Pressure
大体时间：Baseline - 12 Months
|
Mean change in systolic blood pressure (mmHg) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Total Cholesterol
大体时间：Baseline - 12 Months
|
Mean change in total cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Change in Non-HDL Cholesterol
大体时间：Baseline - 12 Months
|
Mean change in non-HDL cholesterol concentration (mg/dL) from baseline to 12 months
|
Baseline - 12 Months
|
|
Body Mass Change at 6 Months
大体时间：Baseline - 6 Months
|
Mean Change in Body Mass (kg) from Baseline to 6 Months
|
Baseline - 6 Months
|
|
Body Mass Change at 12 Months
大体时间：Baseline - 12 Months
|
Mean Change in Body Mass (kg) from Baseline to 12 Months
|
Baseline - 12 Months
|
|
Number of Participants Who Achieved 5% Weight Loss Goal in 12 Months
大体时间：Baseline - 12 Months
|
Proportion of Participants who Reach a 5% Weight Loss Goal at 12 Months, calculated as the percent of all participants for whom the following calculation is greater than or equal to 5%: (Baseline body mass (kg) - Body mass measured at 12 months (kg))/(Baseline body mass (kg))
|
Baseline - 12 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。
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 (实际的)
2019年12月16日
初级完成 (实际的)
2020年6月30日
研究完成 (实际的)
2021年6月30日
研究注册日期
首次提交
2019年6月21日
首先提交符合 QC 标准的
2019年6月24日
首次发布 (实际的)
2019年6月25日
研究记录更新
最后更新发布 (实际的)
2022年2月22日
上次提交的符合 QC 标准的更新
2022年1月28日
最后验证
2022年1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.