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Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes

2021年5月3日 更新者:Kimberly R Azelton、Beacon Health System
Accessible and effective interventions for chronic diseases such as diabetes are especially needed in the under-resourced patient population. This is a pilot randomized control trial compares usual diabetic care to usual diabetic care plus virtual health coaching utilizing lifestyle action plans in under-resourced adult type II diabetic patients. This is a one-site study at an under-resourced family medicine residency clinic. The primary outcome is the change of insulin resistance as measured by HOMA2-IR. Secondary metabolic outcomes are being tracked. Potentially confounding variables related to SDoH, race, and engagement in health coaching are being assessed for. The cost of the intervention as well as expensive healthcare utilization as measured by ER visits are also being tracked.

研究概览

详细说明

Those having difficulty with SDoH (Social Determinants of Health) are associated with a higher incidence of diabetes as well as worse health outcomes. Inexpensive, effective virtual options for chronic diseases conducive to all levels of socio-economic status would be very beneficial. As early as 1934 there have been reports of nutritional interventions preventing and reversing DMII. A recent randomised trial utilizing meal replacement and caloric restriction noted greater diabetes remission rates with greater weight loss. Despite knowledge that weight and dietary factors are at the foundation of DMII incidence, control and even remission, it is challenging to find accessible, effective, community-based interventions.

Culturally sensitive health coaches trained to use motivational interviewing to create specific, measurable, attainable, reasonable and time-bound (S.M.A.R.T.) action plans through shared-decision making and thus personalized to the patients' literacy, resources and motivation level may overcome some of these cultural and literacy barriers. Accessibility is further increased by utilizing phone and text. This allows for low-tech, inexpensive remote patient monitoring. This real-time feedback may further increase patient self-efficacy and engagement. While using health coaching methods may improve diabetic control, the exact content of what should be delivered is unexplored. The mixed results of diabetes remission rates in dietary intervention studies is attributed to delivery of too low a "therapeutic dose" of lifestyle change. Therefore, it is postulated that health coaches personalizing the behavioral interventions that may be most effective in controlling and reversing diabetes may improve insulin resistance in a real-world primary-care based setting to those most challenged by barriers to care.

This is a pilot randomized control trial comparing usual care to usual care plus virtual health coaching utilizing lifestyle action plans in adult type II diabetic patients. This is a one-site study at an under-resourced family medicine residency clinic. The primary outcome is the change of insulin resistance as measured by HOMA2-IR. Secondary metabolic outcomes are being tracked. Potentially confounding variables related to SDoH, race, and engagement in health coaching are being assessed for. The cost of the intervention as well as expensive healthcare utilization as measured by ER visits are also being tracked.

研究类型

介入性

注册 (实际的)

45

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

    • Indiana
      • South Bend、Indiana、美国、46601
        • Beacon Health System

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 至 65年 (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:

  • Diabetes (Hemoglobin A1C 6.5% or higher in the last year) who are regular patients of E. Blair Warner Clinic. English or Spanish speaking patients will be included who are between 18 and 65 years old with a working phone. Subjects recently started on or taking a short dose of medications that are known to influence insulin resistance (i.e. atypical antipsychotics, steroids, thiazides). Subjects (and their providers) on chronic doses of these medications will be asked to keep the dose the same.

Exclusion Criteria:

  • Patients whose preferred language is not English or Spanish will be excluded due to lack of health coaches speaking other languages. Approximately 50% of C-peptide is cleared by the kidney and some studies excluded advanced renal failure. For our study subjects with chronic renal failure with a GFR <45 on most recent blood work will be excluded. Subjects with conditions known to influence insulin resistance (i.e. pregnancy, hemochromatosis, polytransfused individuals) will be excluded. Subjects with syndromic obesity (i.e. hypothalamic obesity, pradi-willi syndrome) or type I diabetes mellitus will be excluded. Subjects with diagnosed diseases that would hinder giving consent or participating in health coaching (i.e. dementia, cognitive impairment) will be excluded. Subjects who have attended an intensive lifestyle change program and/or made an impacting lifestyle change in the last 3 months, such as losing 5% or more of their body weight in the last 3 months will also be excluded.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Usual Diabetic Care
Usual diabetic care for this study will include a diabetic visit with their primary care provider at the beginning and end of the 12 weeks. They will also be asked to continue their current level of physical activity and eating habits.
实验性的:Usual Diabetic Care Plus Virtual Health Coaching
For the duration of the 12 weeks, Healthy at Home will provide health coaching in 10-20 minute phone calls weekly. They will request daily blood glucose logs as this is part of Healthy at Home's normal procedure. The health coach and subject will choose a patient-directed overarching goal such as "lose weight," or improve my blood sugar numbers," etc. that the health coach will then help the patient turn into a SMART goal. They will do this by utilizing a list of lifestyle change categories as top priority goals from which to choose from in their patient-directed health coaching sessions. Texting will be utilized to request daily blood glucose and provide real-time coaching via text.
Culturally sensitive health coaches trained in motivational interviewing provide 10-20 minutes of weekly phone-based health coaching. They not only guide the patient in creating a SMART goal, but assess and build off of the previous weeks' goal and problem-solve with the patient. During the week, the coach and patient text regarding daily blood glucose monitoring with real-time feedback and coaching about the implementation of the patients' goal.

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 of HOMA2-IR
大体时间:Beginning and End of 12 Weeks
Homeostatic Model Assessment of Insulin Resistance as a surrogate measure of upstream diabetic control
Beginning and End of 12 Weeks

次要结果测量

结果测量
措施说明
大体时间
sBP
大体时间:Beginning and End of 12 Weeks
systolic blood pressure in mm Hg
Beginning and End of 12 Weeks
dBP
大体时间:Beginning and End of 12 Weeks
diastolic blood pressure in mm Hg
Beginning and End of 12 Weeks
BMI
大体时间:Beginning and End of 12 Weeks
Body Mass Index as an aggregate of weight and height
Beginning and End of 12 Weeks
Hemoglobin A1C
大体时间:Beginning and End of 12 Weeks
Measure of downstream diabetic control
Beginning and End of 12 Weeks
Change in Diabetic Medications
大体时间:Beginning and End of 12 Weeks
change in number of the diabetic medications at the beginning and end of the 12 weeks
Beginning and End of 12 Weeks
EVS
大体时间:Beginning and End of 12 Weeks
Exercise Vital Sign: minutes of exercise per day * days per week
Beginning and End of 12 Weeks

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:Kimberly R Azelton, MD、Beacon Health System
  • 学习椅:Karin Underwood, MBA、Coach Me Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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)

2020年12月18日

初级完成 (预期的)

2021年5月20日

研究完成 (预期的)

2021年5月20日

研究注册日期

首次提交

2021年4月14日

首先提交符合 QC 标准的

2021年5月3日

首次发布 (实际的)

2021年5月4日

研究记录更新

最后更新发布 (实际的)

2021年5月4日

上次提交的符合 QC 标准的更新

2021年5月3日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

IPD sharing would be considered on a case-by-case basis while in communication with Beacon IRB.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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