Improving Diabetes Outcomes for Persons With Severe Mental Illness
2017年5月7日 更新者：University of North Carolina, Chapel Hill
Persons with severe mental illness are at great risk for developing type 2 diabetes (T2DM).
Unfortunately, persons with mental illness and T2DM are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life.
Evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (RCTs) to examine their feasibility and efficacy.
The purpose of this study is to assess the feasibility of conducting a RCT of a diabetes self-management intervention for persons with severe mental illness and T2DM.
研究概览
研究类型
介入性
注册 (实际的)
18
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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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina At Chapel Hill
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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
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: Type 2 diabetes plus severe mental illness -
Exclusion Criteria: None
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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：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 |
|---|---|
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其他：Self-management and education group
Self-management and education group - 8 weeks of group-based information and activities designed to improve diabetes self-management
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Changes in knowledge of diabetes self-management from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Management Questionnaire.
大体时间：Baseline, 6 months
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Baseline, 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in HBA1c values from baseline to six months.
大体时间：Baseline, 6 months
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Baseline, 6 months
|
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Changes in diabetes self-efficacy from baseline to six months as evidenced by scores on the Stanford Diabetes Self-Efficacy Questionnaire.
大体时间：Baseline, 6 months
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Baseline, 6 months
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Changes in eating self-efficacy from baseline to six months as evidenced by scores on a standardized measure of eating self-efficacy.
大体时间：Baseline, 6 months
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Glynn and Ruderman's (1986) eating self-efficacy scale will be used. Glynn, S.M., & Ruderman, J. (1986). The development and validation of an eating self-efficacy scale. Cognitive Therapy and Research, 10, 403-420. |
Baseline, 6 months
|
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Changes in exercise self-efficacy from baseline to six months as evidenced by scores on a standardized measure of exercise self-efficacy.
大体时间：Baseline, 6 months
|
Bandura's exercise self-efficacy scale will be used.
Bandura, A. (1997).
Self-efficacy: The exercise of control.
New York: W.H. Freeman.
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Baseline, 6 months
|
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Changes in healthy lifestyle activities from baseline to six months as evidenced by scores on a standardized measure of adult health behavior.
大体时间：Baseline, 6 months
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Baseline, 6 months
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Changes in health promoting activities from baseline to six months as evidenced by scores on a standardized measure of health promoting lifestyle activities.
大体时间：Baseline, 6 months
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Baseline, 6 months
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Changes in waist circumference from baseline to six months.
大体时间：Baseline, 6 months
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Baseline, 6 months
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Changes in triceps circumference from baseline to six months.
大体时间：Baseline, 6 months
|
Baseline, 6 months
|
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Changes in subscapular skinfold measurement from baseline to 6 months.
大体时间：Baseline, 6 months
|
Baseline, 6 months
|
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Changes in body mass index from baseline to six months.
大体时间：Baseline, 6 months
|
Baseline, 6 months
|
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Changes in diastolic and systolic blood pressure from baseline to six months.
大体时间：Baseline, 6 months
|
Baseline, 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。
调查人员
- 首席研究员：Gary S Cuddeback, Ph.D.、University of North Carolina, Chapel Hill
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
2013年12月1日
初级完成 (实际的)
2015年6月15日
研究完成 (实际的)
2015年12月31日
研究注册日期
首次提交
2014年1月21日
首先提交符合 QC 标准的
2014年1月31日
首次发布 (估计)
2014年2月4日
研究记录更新
最后更新发布 (实际的)
2017年5月9日
上次提交的符合 QC 标准的更新
2017年5月7日
最后验证
2016年5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.