Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 6
- 主要终点
- Hospitalization for heart failure and cardiac mortality
研究概览
简要总结
Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas.
详细描述
Heart failure is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms and seek out medical attention when appropriate. Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function. Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations. However, many patients ignore symptoms and are reluctant to seek care. Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms.
Traditionally, heart failure patients living in rural areas have had limited access to formal monitoring programs. Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms, specifically excess fluid buildup. The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas.
In this 2-year study, 710 participants will be randomly assigned to either the Fluid Watchers LITE program, the Fluid Watchers PLUS program, or a usual care control group. Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis. All participants will record self-monitoring adherence and contact with healthcare providers. Outcome measures will be assessed during either clinic or home visits at study entry and Months 3, 12, and 24, and will include number of emergency department visits, number of physician visits, heart failure severity, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized for heart failure in the 6 months prior to study entry
- •Able to read and write English
- •Lives independently
排除标准
- •Current participation in a heart failure management program
- •Impaired cognition
- •Serious co-morbidity
结局指标
主要结局
Hospitalization for heart failure and cardiac mortality
时间窗: Measured at Year 2
次要结局
- Heart failure-related emergency department visits (without hospitalization)(Measured at Year 2)
- Unplanned physician visits(Measured at Year 2)
- Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)(Measured at Year 2)
- Quality of life(Measured at Year 2)