JAMA: Consultation+HF education does not reduce death, hospitalizations
Adding a self-management counseling regimen to educational interventions for heart failure (HF) patients did not reduce death or HF hospitalizations, according to a study published in the Sept. 22/29 issue of the Journal of the American Medical Association.

“Patients' nonadherence to heart failure drugs ranges from 30 percent to 60 percent and nonadherence to lifestyle recommendations from 50 percent to 80 percent, with higher rates occurring in more socioeconomically disadvantaged subgroups,” the authors wrote. “To meet the challenge of delivering evidence-based therapies to patients with heart failure, research has turned to the evaluation of disease management, remote monitoring and patient self-management programs.”

To better evaluate the outcomes of self-management consultation in addition to HF education, Lynda H. Powell, PhD, of Rush University Medical Center in Chicago, and colleagues enrolled 902 mild to moderate heart failure patients with reduced or preserved systolic function to the single-center, multiple-hospital Heart Failure Adherence and Retention Trial (HART) conducted between October 2001 and October 2004.

Patients had a median age of 64 and 47 percent were women, 40 percent were of a racial/ethnic minority, 52 percent had an annual family income less than $30,000 and 23 percent had preserved systolic function. The researchers conducted follow-up for two to three years and randomized patients at a 1:1 ratio to receive either one year of treatment and one year of follow-up or one year of treatment and two years of follow-up of either self-management consultation plus education (n=383) or HF education alone (n=435).

For patients who received self-management plus education treatment, researchers performed a group-based HF education and consultation that included 18 two-hour group HF education sessions. In addition, the researchers developed patients' problem solving skills and self-management skills via use of the self-efficacy at self-management scale, a 10 point scale that assessed: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring and the relaxation of response.

According to the researchers the median follow-up time was 935 days—918 days for the self-management group and 963 days in the education group.

All of the 902 patients were administered an active HF treatment, including diuretics, for three months prior to the study. And according to the researchers, patients were taking an average of 6.8 medications and 37 percent of these patients did not adhere to at least 80 percent of the prescribed doses of either ACE inhibitors or beta-blockers.

The medium sodium intake for these HF patients was 3,338 mg/d, well above the recommended 2000 mg/d for HF patients.

The researchers reported that 163 events took place (40.1 percent) in the self-management group and 171 (41.2 percent) in the education group after an estimated 2.56 years of follow-up. These annual event rates were 18.4, based on 883.83 person-years for the self-management arm and 19.2 percent, based on 889.11 person-years in the education group. Both study arms had a mean rate of 0.7 for HF hospitalizations.

Additionally, the researchers reported that there were no differences in NYHA class, six-minute walk, heart rate, respiratory rate, blood pressure, body mass index, quality of life, emotional support or purpose in life between the two patient arms, and no serious or adverse events occurred.

Self-efficacy scores improved by 0.2 points in both groups, while major depressive symptoms decreased by 20 percent in the self-management arm and 22 percent in the education arm. Restricting sodium to 2,400 mg/d or less occurred in 28 percent of patients in the self-management group and 18 percent in the education group. While patients in the self-management group saw a greater improvement in sodium intake compared with the HF education arm, still these numbers were high with 72 percent of the patients having a sodium intake that was greater than 2,400 mg/d.

The researchers reported that patient adherence to either prescribed ACE inhibitors of beta-blockers increased by seven percentage points.

Lastly, the researchers found a difference in event rates for those with lower incomes totaling less than $30,000. Patients who received education alone had a 44 percent faster time to event then those randomized to self-management; however, the researchers found no statistically significant differences in the two groups in patients with incomes totaling greater than $30,000.

“Like any chronic illness, HF should be managed collaboratively, such that the clinician prescribes evidence-based therapy and an informed, proactive patient implements it,” the authors wrote. “To enable patients to be proactive, we reasoned that HF education should be augmented by training in self-management skills to help patients implement the education. This hypothesis was not supported.

“Consistent with past trials, self-management training plus education had no benefit compared with education alone in reducing death or HF hospitalization in patients with mild to moderate HF.”

The researchers said that because of the high number of HF patients, cost-effective and innovative approaches to patient management are needed.