A Reinforcement Approach to Improve Diabetes Management
2021年1月15日 更新者:Yale University
A Reinforcement Approach to Improve Diabetes Management - Randomized Trial
The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D.
The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals.
A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.
研究概览
研究类型
介入性
注册 (实际的)
62
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
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale University School of Medicine
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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
12年 至 21年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- age 12-21 years old;
- diagnosis of type 1 diabetes (T1D) >12 months via ADA guidelines
- receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
- SMBG user with clinical recommendations to test >4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);
- access to a computer with internet for uploading and sending SMBG data;
- access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
- English speaking, able to read at >5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.
Exclusion Criteria:
- have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
- have a major visual impairment;
- have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
- plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
- are participating in another clinical trial.
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: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:Reinforcement for performing BG testing
Subjects will receive reinforcement for BG testing.
The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
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Subjects will receive reinforcement for BG tests.
The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
Subjects receive standard of care
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有源比较器:No reinforcement for BG testing
Subjects will receive standard of care without reinforcement for Self Monitoring Blood Glucose
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Subjects receive standard of care
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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 |
|---|---|---|
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To determine if the reinforcement intervention increases SMBG testing.
大体时间:6 Months
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The number of SMBG tests will be assessed via glucometer uploads, and the proportion of days on which at least 4 tests occurred as well as the longest number of consecutive days on which SMBG tests occurred at frequencies of >4 times/day will be calculated.
The hypothesis is that patients assigned to the reinforcement intervention will conduct more SMBG tests, have greater proportions of days with >4 tests, and have longer durations of appropriate testing frequencies than patients assigned to usual care.
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6 Months
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To assess if the intervention reduces A1c
大体时间:6 months
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Patients randomized to the reinforcement intervention are expected to have greater decreases in A1c over time than patients assigned to usual care.
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6 months
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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。
合作者
调查人员
- 首席研究员:William Tamborlane, MD、Yale University
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
2014年7月1日
初级完成 (实际的)
2019年11月1日
研究完成 (实际的)
2019年11月1日
研究注册日期
首次提交
2014年6月16日
首先提交符合 QC 标准的
2014年6月16日
首次发布 (估计)
2014年6月19日
研究记录更新
最后更新发布 (实际的)
2021年1月19日
上次提交的符合 QC 标准的更新
2021年1月15日
最后验证
2021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.