Examining the Feasibility of EMPOWER - A Personalized Adherence Enhancement Intervention for Older Post-discharge Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mean change in medication adherence
研究概览
简要总结
The purpose of this study is to see how investigators may best improve treatment adherence and disease management for heart failure after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of future hospitalizations. In this study, a trained nurse interventionist will work with the participants to develop a personalized adherence enhancement strategy for heart failure diagnosis. The personalized adherence enhancement strategy is called EMPOWER.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of moderate/severe heart failure at hospital admission, defined by ICD codes (ICD-9 428 or ICD-10 150), New York Heart Association class III/IV, and left ventricular ejection fraction less than or equal to 40% (i.e., echocardiography)
- •discharge from heart failure-led hospitalization to home health care in approximately the previous week
- •intact or mildly impaired cognitive function (Montreal Cognitive Assessment eligibility scores greater than or equal to 18)
- •primary residence in four counties within 30 minutes distance to the University of Rochester
排除标准
- •end-of-life prognosis in the following 6 months that make it difficult to examine the changes in heart failure outcomes
- •currently receiving hospice care
- •conditions that impact the receipt of the intervention such as active suicidal ideation that is identified at baseline using the Geriatric Depression Scale and the Geriatric Suicide Ideation Scale
- •being non-English speaking
- •having serious visual and or hearing impairment
结局指标
主要结局
Mean change in medication adherence
时间窗: week 1 to 3 months
Adherence will be calculated either by manual pill counting or by the Medication Event Monitoring System, a microelectronic monitoring device on the cap of medication containers.
mean change in adherence to low-sodium diet
时间窗: week 1 to 3 months
Adherence to low sodium diet will be assessed by the Dietary Sodium Restriction Questionnaire (DSRQ). The DSRQ is composed of 3 subscales: 1) attitude toward the behavior, 2) subjective norm, and 3) perceived behavioral control. Attitude. There are 6 items in the Attitude subscale. The scores on this subscale ranged from 6 to 30, where a higher score indicates correct attitudes (better knowledge) about following a low-sodium diet. Subjective norm. There are 3 items in the Subjective Norm subscale. The scores on this subscale ranged from 3 to 15, where a higher score indicates heavier influence of subjective norm of social contacts on one's adherence to low-sodium diet. Perceived behavioral control. There are 7 items in the Perceived Behavioral Control subscale. The scores on this subscale ranged from 7 to 35, a higher score indicates a higher likelihood for each item to be a barrier in adherence to low-sodium diet.
次要结局
未报告次要终点
研究者
Jinjiao Wang
Assistant Professor
University of Rochester