Heart Failure Adherence and Retention Trial (HART)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 902
- 试验地点
- 2
- 主要终点
- Time until all-cause death or heart-failure hospitalization
研究概览
简要总结
This study will test whether a self-management (SM) intervention, compared to usual care, will reduce the risk for adverse clinical outcome in patients with mild to moderate heart failure.
详细描述
BACKGROUND:
Heart failure is a major disabling disease for American adults, affecting an estimated 4.9 million individuals. Heart failure is associated with enormous health care expenditures. This is because it is a progressive chronic condition that is characterized by disabling symptoms that limit independence and result in multiple hospitalizations and referrals to long-term care. The emergence of heart failure as a major public health problem is related to the unintended result of both an aging population and the success in reducing mortality from cardiovascular disease. Non-adherence to medications is a key problem in the treatment of heart failure, with adherence rates ranging from 20% to 90%. There is a clear need, therefore, to develop interventions that improve adherence in patients with heart failure.
DESIGN NARRATIVE:
This is a single-site, partially blinded, randomized clinical trial of 900 patients with systolic or diastolic dysfunction, and New York Heart Association (NYHA) functional class II or III. Patients will be recruited over a period of 2 years from seven hospitals. Patients will be randomly assigned to either a SM intervention or attention control. The SM group will meet 18 times for 2 hours over 1 year. These group sessions will teach patients how to use five basic self-management skills (self-monitoring, environmental restructuring, social support, cognitive restructuring, and the relaxation response) to help build self-efficacy and maintain it after the treatment has been discontinued. The attention control arm will consist of an educational intervention which includes 18 mailings of the American Heart Association Tip Sheets over the course of the first year, plus a telephone follow-up with the patient after each mailing to check receipt and comprehension of the Tip Sheet, and to address any questions about the Tip Sheet. Treatment effects will be evaluated using the primary outcome of hospitalization for heart failure or death, and the secondary outcomes of progression of heart failure, quality of life, and health care costs. Potential mediators of effectiveness will include improved adherence and improved psychosocial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA classification of II or III
- •LVEF of 40% or less
排除标准
- •Uncertain 12-month prognosis
- •Potential cardiac transplant within 1 year of study entry
- •Severe aortic stenosis
- •Uncontrolled ventricular tachycardia
- •Non-cardiac causes of heart failure symptoms (i.e., peripheral vascular disease, chronic obstructive pulmonary disease, and arthritis)
- •Major psychiatric co-morbidity
- •Unstable angina, myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 1 month prior to study entry
结局指标
主要结局
Time until all-cause death or heart-failure hospitalization
时间窗: Measured over the two years of study follow-up.
This is a composite outcome, measuring time from randomization to occurrence of death due to any cause or a hospitalization that is adjudicated to be due to heart-failure, among participants who experience either (or both) of these events. Only the first occurrence of either of these events is considered.
次要结局
- Progression of heart failure(Measured over the two years of study follow-up)
- Quality of life(Measured over the two years of study follow-up)
- Health care costs(Measured over the two years of study follow-up)
- Time until all-cause death or all-cause hospitalization(Measured over the two years of study follow-up)
研究者
Lynda Powell, PhD, MEd
Chair, Department Preventive Medicine
Rush University Medical Center