Coping Skills and Heart Failure: Outcomes and Mechanisms

Over 5 million Americans suffer from heart failure (HF), with an associated annual health
care cost in excess of $33 billion. With 500,000 new cases developing each year, HF is the
only major cardiovascular disease that is increasing in prevalence. Despite intensive
medical therapy, symptom instability and clinical deterioration are common and lead to
frequent physician visits, hospitalization, and ultimately death. HF symptoms, including
dyspnea and fatigue, are a major source of distress for patients with HF, and often impose
severe limitations on their daily activities. Depression also is common in HF patients, and
its presence is associated with increased risk of hospitalization and mortality, independent
of disease severity. There is growing evidence that behavioral management is a critical
component of living with HF that can reduce hospitalizations and help optimize health
status. Although previous studies have demonstrated that case-management programs are
effective, benefits appear to be short-lived once ongoing care is reduced. Prior research
from our laboratory and others has shown that coping skills training (CST), designed both to
teach patients self-management skills and to cope more effectively with psychological
distress associated with their medical condition, is effective for such chronic diseases as
diabetes, ischemic heart disease, and lung disease. However, CST has not yet been evaluated
as an intervention to facilitate self-management of HF. We propose a randomized clinical
trial comparing a 16-week CST intervention with Extended (Standardized) Care in a study
sample of 200 HF outpatients, who are receiving medical treatment for HF according to
current clinical practice guidelines. The CST intervention, delivered over the telephone, is
designed reduce stress and depression and to improve aspects of health behavior that are
related to HF outcomes, including symptom monitoring, medication adherence, dietary
compliance, and physical activity. Before and following treatment, patients will be
carefully assessed on important intermediate medical endpoints including HF disease
biomarkers (B-type natriuretic peptide, ejection fraction, vascular endothelial function,
autonomic regulation, and inflammatory activity), as well as on quality of life (QoL)
indicated by both physical and psychosocial functioning. Effects of CST on clinical outcomes
will be evaluated according to all-cause hospitalizations or mortality over a median
follow-up period of 3 years. The data generated by the proposed study will provide important
insights regarding the value of CST over and above usual medical care. If successful, we
believe that the study findings should translate into initial recommendations for the
incorporation of CST into self-management behavioral interventions as cost-effective
approaches to enhance disease management, QoL and longevity in HF patients.

Inclusion Criteria:

- Men or women aged 21 years or older

- New York Heart Association (NYHA) Class I-IV HF of at least 3-months duration

- Left ventricular Ejection Fraction (EF) < 40% by left ventricular angiography,
nuclear wall motion study, or echocardiography, within 6 months of study enrollment

- Undergoing treatment with a stable medication regimen.

Exclusion Criteria:

- Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty(PTCA),
Coronary Artery Bypass Graft (CABG) within 3 months of enrollment

- HF due to correctable cause or condition such as uncorrected primary valvular disease

- Alcohol or drug abuse within 12 months

- Illness such as malignancies that are associated with a life-expectancy of < 12
months

- Current pregnancy

- Inability to provide informed consent