The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities
Partnerships for Cardiometabolic Disparities in Native and Pacific People
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Confirmed diagnosis of diabetes mellitus
- HbA1c >7%
- Not planning to move out of the State
- Able to fully participate in either intervention or usual care arms.
Exclusion Criteria:
- Pregnancy
- End Stage Renal Disease requiring dialysis
- Any medical condition that would prevent participation in all aspects of the study protocol (including major psychiatric diagnosis) or with < 6 month expected survival, as determined by the patient's physician.
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 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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其他：Intervention
Patient participants in the intervention arm will receive diabetes self-management program, Ma ka hana ka ̒ike which includes 5 interactive group sessions lasting 1-1/2 hours in length delivered by community peer educators once a month for 4.5 months. After 4.5 months, the patient will receive 4 monthly boosters by mail that will reinforce information from the Ma ka hana ka ̒ike program. Completion of diabetes process and glycemic outcomes will trigger the modest financial incentives. Health care provider participants in the intervention arm will receive educational resources, Hanapū Provider Toolbox to guide their patients to optimal glycemic control.They will receive modest financial incentives when their patients complete clinical tests and achieve glycemic target. |
Ma ka hana ka ̒ike is a self-management program for diabetic patients which includes 5 interactive group sessions lasting 1-1/2 hours in length delivered by community peer educators once a month for 6 months.
Hanapū Provider Toolbox is an educational tools that will aid the health care providers in guiding their patients to optimal glycemic control.
|
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无干预：Usual Care
Patient participants in the usual care arm will receive 5 mail-out diabetes self management education booklets endorsed by the American Diabetes Association (ADA) and the National Institute for Diabetes, Digestive and Kidney disease for 4.5 months. Patients will see their doctor according to usual care practice. After 4.5 months, the patients will receive 4 monthly boosters in mail reinforcing the previous mail-out diabetes self-management program materials. Health care provider participants in the usual care arm will receive the latest ADA guidelines to use in their treatment plan of their patients. |
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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Change of HbA1c
大体时间：Baseline, 4.5 months and 9 months
|
HbA1c assessment will be done at baseline and during the intervention follow up periods (4.5 and 9 months) to see incremental improvement (0.5% decrease in HbA1c) or achieving optimal control (HbA1c < 7%).
|
Baseline, 4.5 months and 9 months
|
合作者和调查者
调查人员
- 首席研究员：Marjorie K Mau, MD、The University of Hawaii
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CHS#18539
- 3P20MD000173-09S1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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.
Ma ka hana ka ̒ike的临床试验
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Calibr, a division of Scripps ResearchCalifornia Institute for Regenerative Medicine (CIRM)完全的
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Charles University, Czech Republic未知