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Promoting Self-Management in Low Income African Americans Living With Hypertension (ENCM)

2016年5月11日 更新者:Bev Zabler
The specific study aims are to: 1) examine differences between an Ecological Nursing Case Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention.

研究概览

地位

完全的

条件

详细说明

Health outcomes of chronically ill low-income adults are costly in both fiscal and human terms. Although advances have been made in understanding how nurse case management (NCM) can contribute to self-management (SM) behaviors, the factors that contribute to sustained SM behaviors in low-income African American populations are not well understood. This study will examine the impact of Ecological Nurse Case Management (ENCM) on self-management behaviors, health status, and self-efficacy of poor, chronically ill, African American adults. In addition, we will explore moderating effects to determine if the ENCM intervention is differentially effective based on gender or perceived stress. The study will use the UWM Automated Community Health Information System, a relational electronic health record, to document the individualized ECNM intervention and dose of the intervention. The specific study aims are to: 1) examine differences between an ENCM treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention. Acknowledging the small sample size, mixed models for repeated measures data (at baseline and M1, 3, and 6 post-intervention) will be fit to interactions involving moderating variables of gender and stress. The ENCM intervention draws on evidence that given the proper tools (i.e., knowledge, skills and support), individuals can learn to better self-manage their symptoms on a day to day basis and better utilize the health care resources available to them.

研究类型

介入性

注册 (实际的)

59

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

    • Wisconsin
      • Milwaukee、Wisconsin、美国、53201
        • University of Wisconsin Milwaukee College of Nursing

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

30年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Hypertension diagnosis Attend Bread of Healing Clinic

Exclusion Criteria:

  • No Hypertension diagnosis Do not Attend Bread of Healing Clinic

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:预防
  • 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
实验性的:Ecological Nurse Case Managemnt
Ecological Nurse Case Management (ENCM) group receives 6 months of ENCM services in addition to their usual primary care services at the study site.
The Ecological Nurse Case Management (ENCM) intervention allows for individualized case management based on client preferences through mutual goal setting and client choice points, nursing assessments, the nurse's analytic decision-making process and critical thinking, and nursing actions.
无干预:Comparison
Usual Clinical Care - is the usual primary care services delivered at the site of the study, a free clinic.

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
Change measures
大体时间:@ baseline,one month, three months, six months
NIH Toolbox Perceived Stress Survey NIH Toolbox Self-efficacy Survey Hypertension Self-Care Profile Blood pressure, BMI and Waist Circumference changes Hypertension Self-Care Profile
@ baseline,one month, three months, six months

次要结果测量

结果测量
措施说明
大体时间
Automated Community Health Information System (ACHIS) data elements
大体时间:6 months
Data elements of ACHIS, including Omaha System informatics codes, will be used to measure the intervention dose and intervention outcomes of nurse rated knowledge and client self-reported health status.
6 months

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。

赞助

调查人员

  • 研究主任:Rachel Schiffman, Ph.D.、University of Wisconsin-Milwaukee College of Nursing

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)

2016年4月1日

研究完成 (实际的)

2016年4月1日

研究注册日期

首次提交

2015年5月28日

首先提交符合 QC 标准的

2015年5月28日

首次发布 (估计)

2015年5月29日

研究记录更新

最后更新发布 (估计)

2016年5月13日

上次提交的符合 QC 标准的更新

2016年5月11日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 144-PRJ94IR

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

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