Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial.

CONTEXT: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations. OBJECTIVE: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization. DESIGN, SETTING, AND PATIENTS: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years. INTERVENTIONS: All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice. MAIN OUTCOME MEASURE: Death or heart failure hospitalization during a median of 2.56 years of follow-up. RESULTS: Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life. CONCLUSIONS: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018005.

The Heart Failure Adherence and Retention Trial (HART): design and rationale.

BACKGROUND: Heart failure (HF) is increasing in prevalence and is associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but nonadherence is high, ranging from 30% to 80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations. TRIAL DESIGN: The Heart Failure Adherence and Retention Trial (HART) evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite end points of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary end points included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was composed of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline examination, patients were randomized to SM or education control, received 18 treatment contacts over 1 year, annual follow-ups, and 3-month phone calls to assess primary end points. Self-management treatment was conducted in small groups and aimed to activate the patient to implement HF education through training in problem-solving and 5 SM skills. The education control received HF education in the mail followed by a phone call to check comprehension. CONCLUSIONS: The significance of HART lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from behavioral medicine.

Understanding African-American participation in a behavioral intervention: results from focus groups.

Heart failure (HF) is an increasingly prevalent condition contributing to significant morbidity and mortality among African-Americans. The Heart Failure Adherence and Retention Trial (HART) is the largest NHLBI funded behavioral clinical trial of patients with HF (R01 HL65547). The HART trial has recruited approximately 40% minority participants, with 33% being African-American. The purpose of this qualitative study is to conduct an in-depth examination of the subjective experience of African-American participants in the intervention arm of the HART. Five focus groups were conducted with a total of 25 participants. The mean age of those attending was 55 years, with a range between 39 and 82 years, 52% of the participants were female, and 92% were African-American. Participants gained overall general medical knowledge about HF and how HF influenced their own lives. Participants appeared not only to understand the self-management skills that were taught; but also how to apply them. They also demonstrated understanding of the connection between lifestyle and HF. Factors that may promote retention include mutual support, the opportunity to engage in meaningful social activity, and feeling cared for. Factors that may limit retention include anxiety and denial about HF and logistical and emotional barriers to attending groups. Factors with unclear effects on retention include remuneration, ethnicity of the group leader, and the role of religious or spiritual content in meetings. While a number of perceived benefits exist to group participation, there are significant and logistical barriers to retention. Ongoing attention to cultural sensitivity is a likely factor in successful retention of study participants.

Increasing self-management skills in heart failure patients: a pilot study.

Nonadherence to medical treatment among heart failure patients is high and results in frequent exacerbations and premature death. This treatment-only pilot study examined whether a year-long group-based self-management intervention is feasible and improves self-management skills in patients with mild-to-moderate heart failure (ejection fraction < or =40% and New York Heart Association functional class I, II, or III). A total of 31 of 100 recruited patients (31%) agreed to participate. Twenty-six (84%) completed the year-long self-management program. Compared with baseline, the intervention was associated with an increase in overall self-efficacy in practicing self-management skills (p<0.001) and in four of five specific self-management skills. Patients and their group leaders also reported an increase in actual use of self-management skills (p<0.001) and in several psychosocial outcomes. The success of this pilot study suggests the need for a randomized clinical trial to test the efficacy of group-based self-management training on medical outcomes.