Investigating Pain in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 349
- 试验地点
- 14
研究概览
简要总结
Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the presence of pain.
The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence & Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain.
Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.
详细描述
Subjects will be recruited via physicians and nurses providing their care in clinical sites who are members of PC-HEART. PC-HEART is a volunteer collaborative with clinician-investigators at 60 sites nationally that include hospice organizations and heart failure providers in academic, Health Maintenance Organization (HMO) and community settings. Our goal will be to enroll 400 patients with 135 in hospice care and 265 in outpatient settings (a mix of HMO, community practice, VA, and academic centers) who are members of the Palliative Care- Heart Failure Education And Research Trials (PC-HEART) collaborative. We will strive for broad representation of patients living in the community with about one-third African American patients (who often present for initial treatment with advanced heart failure) and at least one-half elderly (who have high prevalence of both pain and heart failure).
We will use standardized tools to survey patients, as follows:
Pain & other symptoms (Assessed at enrollment and one-two weeks later):
Memorial Symptom Assessment Scale- HF (MSAS-HF) Short-form McGill pain questionnaire (SF-MPQ) Brief Pain Inventory (BPI)
Heart-failure specific measures (Assessed at Enrollment):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Advanced HF (Stage D or advanced Stage C HF) with:
- •symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function ("diastolic heart failure") Outpatient care setting (office, clinic or home hospice).
- •Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + β-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will exclude those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered "advanced Heart Failure" but are not on recommended medications.
- •Can be awaiting LVAD, transplantation or other procedure
- •Age > 18 years and able to sign informed consent to participate
排除标准
- •Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent.
- •Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis.
- •Patient on hemodialysis or receiving mechanical ventilation
- •Patients receiving investigational agents or devices.
- •Patients who have received heart transplant or a destination Left Ventricular Assist Device