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临床试验/NCT01530958
NCT01530958已完成不适用

The Kidney Awareness Registry and Education Study

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
375
试验地点
4
主要终点
Change in blood pressure measurement at baseline and at one year follow-up

研究概览

简要总结

The purpose of this study is to evaluate the feasibility and acceptability of two different interventions aimed at improving health outcomes among patients with chronic kidney disease (CKD), who are at high risk of CKD progression. Specifically, this study will examine how best to implement a provider-level intervention (access to a CKD-registry) and a patient-oriented intervention (automated telephone self-management (ATSM) + health coach) on patient health outcomes, with a 2x2 factorial design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with CKD (defined as estimated Glomerular Filtration Rate < 60ml/min/1.73m2 or proteinuria consistently over 3 months) who speak English, Spanish or Cantonese and have a primary care provider

排除标准

  • Kidney transplant recipients; pregnant women; individuals with an eGFR <15 ml/min/1.73 m2; prevalent dementia; impaired cognition or severe mental illness; expected life expectancy <6 months; no phone access; self-reported hearing impairment; severe visual impairment preventing use of a touch-tone telephone keypad; and non-study language

研究组 & 干预措施

ATSM + Health Coach and CKD Registry

Experimental

干预措施: ATSM + Health Coach (Behavioral)

CKD Registry

Active Comparator

干预措施: CKD Registry (Behavioral)

ATSM + Health Coach

Active Comparator

干预措施: ATSM + Health Coach (Behavioral)

Usual Care (no interventions)

Placebo Comparator

干预措施: Usual care (Behavioral)

ATSM + Health Coach and CKD Registry

Experimental

干预措施: CKD Registry (Behavioral)

结局指标

主要结局

Change in blood pressure measurement at baseline and at one year follow-up

时间窗: Baseline and one year follow-up

Blood pressure will be measured at baseline and also at the follow-up visit at one year

次要结局

  • Change in CKD awareness, functional status, and symptoms at baseline and at one year follow-up(Baseline and one year follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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