跳至主要内容
临床试验/NCT01894750
NCT01894750已完成1 期

Building Skill in Heart Failure Self-Care: A Community Based Intervention

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
75
试验地点
2
主要终点
Change in baseline heart failure self-care score at one month

研究概览

简要总结

The purpose of this study is to pilot and feasibility test an innovative cognitive behavioral intervention to improve heart failure self-care among community dwelling older adults.The primary aim of this study is to test the effect of the intervention on improving heart failure self-care, knowledge and Health related quality of life at 1 month and 3 months. We will test three hypotheses comparing 60 older adults with heart failure randomly assigned to either the intervention or a control group:

Hypothesis 1. Participants in the intervention group will have significantly improved heart failure self-care than control participants.

Hypothesis 2. Participants in the intervention group will have significantly improved knowledge about heart failure and heart failure self-care than control participants.

Hypothesis 3. Participants in the intervention group will have significantly better Health Related Quality of Life than control participants.

A secondary exploratory aim is to assess and describe implementation feasibility of providing a heart failure self-care intervention in a community group setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • diagnosis of chronic HF
  • able to read and speak English or Spanish
  • over age 50

排除标准

  • history of prior neurological event (e.g., stroke, head injury, encephalopathy) that could cause dementia
  • unable to perform tests or participate in the intervention session (e.g., inability to communicate verbally, major visual impairment, or severe and uncorrected hearing loss).
  • living in a nursing home or other long term care facility

结局指标

主要结局

Change in baseline heart failure self-care score at one month

时间窗: Change from baseline heart failure self-care at 1 month

Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline at one month will be assessed.

Change in baseline heart failure self-care score at 3 months

时间窗: Change from baseline heart failure self-care at 3 months

Heart failure self-care is measured by the valid and reliable instrument the Self-Care of Heart Failure Index. Change in scores from baseline to 3 months will be assessed.

次要结局

  • Change in baseline Heart failure knowledge score at 3 month(Change in baseline Heart failure knowledge score at 3 month)
  • Change in baseline Heart failure knowledge score at 1 month(Change in baseline Heart failure knowledge score at 1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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