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

Abstract

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.

Figure 1

Trial Profile

Figure 2

Time to Death or Heart Failure Hospitalization by Treatment Arm

Figure 3

Time to Death or Heart Failure Hospitalization in Pre-Specified Baseline Subgroups

Figure 4

Time to Death or Heart Failure Hospitalization by Treatment Arm in Low- and High-Income Subgroups