Group-based Chronic Kidney Disease Care
研究概览
详细说明
This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.
There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Bronx、New York、美国、10461
- Albert Einstein College of Medicine
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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:
- Adolescent Age ≥12 years old
- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider)
- Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95 percentile (based on sex and age) at 2 clinic visits in the past year
- For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2)
- For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension
- Prescription for anti-hypertensive medication (in adults)
- Unwillingness to accept random assignment
- Unwillingness to provide informed consent
Exclusion Criteria:
- Transplanted organ
- Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
- Plans to relocate out of New York City in the next 6 months
学习计划
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：Group-based Care
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
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There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
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无干预：Usual Care
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
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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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Blood pressure control
大体时间：6 months
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The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
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6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Accelerometer
大体时间：6 months
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Evaluate effects of group-based care on physical activity
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6 months
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Medication Adherence
大体时间：6 months
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Measured by the Morisky 8-item Medication Adherence scale.
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6 months
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Quality of Life
大体时间：6 months
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We will collect quality of life measurements using the Peds QL in the adolescent group and the SF-36 in the adult sample.
We want to evaluate whether group-based care may lead to improved or worse reported quality of life in participants.
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6 months
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Health Resources and Services Administration (HRSA)
大体时间：6 months
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Evaluate patient and provider satisfaction
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6 months
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合作者和调查者
出版物和有用的链接
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
Group-based Care的临床试验
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中