Promoting Patient-Centered Care Through a Heart Failure Simulation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results
研究概览
简要总结
The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a "living with HF at home" simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Male or female > 18 years of age.
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis.
- •Heart failure of either preserved or reduced ventricular function.
排除标准
- •Patients requiring ICU monitoring
- •LVAD candidate/recipient
- •Cardiac transplant candidate/recipient
- •Terminal illness (other than HF) with expected survival of less than 1 year
- •Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
- •Inability to comply with planned study procedures
- •Active illicit drug use
- •Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- •Other conditions that in the opinion of the Primary Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
研究组 & 干预措施
Full simulation and education
Patients who will receive full simulation and education session prior to discharge.
干预措施: Full simulation and education (Behavioral)
See simulation room, usual education
Patients will be shown the simulation room prior to discharge but will only receive usual education.
干预措施: See simulation room, usual education (Behavioral)
Usual care
Patients will receive usual care by bedside nurse.
结局指标
主要结局
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results
时间窗: 30 days
The mean differences in heart failure knowledge (from study enrollment to the 30 day study follow up) in each of the arms as assessed by the MLHFQ. Lower scores indicate improvement and a better health-related quality of life (HRQoL). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.
次要结局
未报告次要终点