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临床试验/NCT00166049
NCT00166049已完成不适用

A Family Partnership Intervention in Heart Failure

Emory University8 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
8
主要终点
Adherence to dietary sodium and medication taking behavior

研究概览

简要总结

The purpose of the Education and Supportive Partners Improving Self-Care (ENSPIRE) study is to compare the effect of a Family Partnership Intervention (FPI) over patient and family education and usual heart failure care on physical and mental health outcomes over an 8-month period. The study will examine three ways of giving heart failure patients and their family members information. This study will help scientists determine if learning these communication skills will help people with heart failure to better manage their symptoms and improve their health outcomes.

详细描述

Heart failure is a condition where the heart's pumping ability is reduced, causing shortness of breath, fatigue, fluid-weight gain, and swelling in the abdomen or legs among other symptoms. HF patients can learn to manage their diet, exercise, and medications to reduce these symptoms. Research has shown that people who learn communication skills that involve problem solving and support are often more successful at maintaining lifestyle changes, such as diet and exercise, than those who do not receive this type of training. Routine heart failure care varies, but usually includes patient education about medications and a low sodium diet to prevent fluid buildup and dietary fluid restriction. This study will help advance the scientific understanding of how to best influence and sustain recommended lifestyle changes for HF patients.

The study will investigate three ways of giving HF patients and their family members information. The first method is routine HF care; this serves as the control group. The second method adds a patient and family HF education protocol to routine HF care, and the third method adds a Family Partnership Intervention (FPI). The FPI is an experimental procedure that involves discussion and training in ways to improve communication within families. The study takes place over the course of a year. Two hundred sixty two people and their family members will be asked to participate from Emory, Crawford Long, the VA Medical Center and Grady Healthcare System.

Procedures:

All groups will participate in the following activities:

  • Complete questionnaires at start of study, then 4 and 8 months afterward (3 times)
  • Keep four appointments lasting 1- 4 hours at the General Clinical Research Center (GCRC) located at Emory or Grady Hospital
  • Collect 24-hour urine specimens, one at the start of the study, then 4 and 8 months afterward (3 times)
  • Keep a 3-day food record, writing down everything you eat and drink, starting two days before each 24-hour urine collection (3 times)
  • Use a medication monitoring system attached to the bottle cap of your heart failure medications
  • Take a six-minute walk test in which you walk for up to six minutes at the start of study and then 4 and 8 months afterward (3 times)
  • Provide blood samples for Brain Natriuretic Peptide (BNP) levels to determine the level of heart failure present at the start of the study and then 4 and 8 months afterward (3 times)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

年龄范围
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented diagnosis of heart failure (New York Heart Association [NYHA] Class II or III)
  • Aged 21-79
  • Currently taking angiotensin-converting enzyme (ACE) inhibitor and diuretic medications
  • Recommended to exercise and low sodium diet
  • Willing to participate in educational sessions with a family member
  • Willing to spend a minimum of 9 hours and a maximum of 15 hours over an 8-month period
  • Willing to travel to either Emory University Hospital or Grady Memorial Hospital General Clinical Research Center (GCRC) for study activities

排除标准

  • NYHA Class I or IV heart failure
  • Heart attack within the last 6 months
  • Kidney failure
  • Significant angina/chest pain
  • Inability to read and write English

结局指标

主要结局

Adherence to dietary sodium and medication taking behavior

时间窗: 4 and 8 months after baseline enrollment.

Physical status: 6-minute walk and brain natriuretic peptide

时间窗: 4 and 8 months after baseline enrollment.

Psychological status: depressive symptoms

时间窗: 4 and 8 months after baseline enrollment.

Health related quality of life

时间窗: 4 and 8 months after baseline enrollment.

次要结局

  • Health resource utilization (HRUQ)(4 and 8 months after baseline enrollment.)
  • Autonomy support (AS)(4 and 8 months after baseline enrollment.)
  • Perceived family criticism(4 and 8 months after baseline enrollment.)
  • Knowledge(4 and 8 months after baseline enrollment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra B. Dunbar, RN

Professor, Emory University, Nell Hodgson Woodruff School of Nursing

Emory University

研究点 (8)

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