Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Subject retention
研究概览
简要总结
EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
- •NYHA Class ≥ II
排除标准
- •Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total score of 23 or lower
- •Lack of convenient internet access outside of hospital
- •Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (SCID)
- •Severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning)
- •History or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (SCID)
- •Life-threatening co-morbidity with the likelihood of 50% mortality in one year
- •Active suicidal ideations
- •Female patients of childbearing potential
- •Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days
- •Uncorrected hypothyroidism or hyperthyroidism
研究组 & 干预措施
Psycho-Behavioral Intervention
Williams LifeSkills modules which cover 10 core skills designed to improve coping skills, stress management and interpersonal relationships: 1) being aware of negative thoughts and feelings, 2) making a decision, 3) deflection skills, 4) problem solving or action skills, 5) assertion, 6) saying "no", in addition to the following preventive skills: 7) speaking up, 8) listening, 9) empathy and 10) increasing positives
干预措施: Williams LifeSkills (Behavioral)
结局指标
主要结局
Subject retention
时间窗: 6 month
Percentage of subjects who complete the intervention
次要结局
未报告次要终点