NCT00439842已完成不适用
HF Group Clinic Appointments: Rehospitalization Prevention
Carol Smith, RN, PhD, FAAN2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2007年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- rehospitalization or death
研究概览
简要总结
The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.
It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.
详细描述
Aim 1 Hypothesis:
- The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
- The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
- Health Services Use will be lower in HFcareGroup than standard care group at 12 months.
Aim 2 Hypothesis:
- The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
- A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •18 years or older
- •speak English/Spanish
- •receiving treatment for congestive heart failure
- •receiving IV diuretics
- •2 or more HF symptoms
- •be able to participate in follow up visits
排除标准
- •primary right-sided heart failure
- •HF transient & related to acute MI
- •HF due to correctable cause
- •being scheduled for coronary revascularization or any readmission
- •receiving infusion for HF therapy within 2 weeks
- •having co-morbidities, life expectancy < 12 months
- •severe cognitive impairment
- •D/C to nursing facilities or rehab unit
- •Currently enrolled in an intervention study or HF management program
- •being or planning to become pregnant within 12 months
- •severe cognitive impairment
结局指标
主要结局
rehospitalization or death
时间窗: 12 months
次要结局
- functional health status, quality of life, satisfaction with health care, health services use(12 months)
- HF self-management:problem-solving, self-care behaviors(6 and 12 months)
- heart failure knowledge and preparedness for home care(6 and 12 months)
研究者
Carol Smith, RN, PhD, FAAN
Professor, School of Nursing
University of Kansas Medical Center
研究点 (2)
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