An intervention to teach patients self-management of their chronic heart failure failed to reduce mortality or hospitalizations for the disorder, compared with patient education alone, according to a report in the Sept. 22/29 issue of JAMA.
Nonadherence to heart failure medications ranges from 30% to 60%, and nonadherence to lifestyle recommendations ranges from 50% to 80% in the general population. Previous assessments of self-management techniques to improve adherence have been limited by their small sample sizes, short durations, and inadequate follow-up time, said Lynda H. Powell, Ph.D., of the department of preventive medicine at Rush University Medical Center, Chicago, and her associates.
The investigators designed HART (Heart Failure Adherence and Retention Trial) to have the size, duration, methodologic rigor, and representation of typical HF patients so that it would provide more conclusive results. They assessed mortality and HF hospitalizations after 1 year of self-management counseling and another 1-2 years of follow-up in 902 patients with mild to moderate HF who were recruited at 10 hospitals throughout Chicago.
In all, 451 patients (average age, 64 years) were randomly assigned to receive the study intervention, and the other 451 served as a control group.
Slightly fewer than half of the study subjects were women, and 40% were members of racial/ethnic minority groups. Overall, 23% had preserved systolic function and the remainder had impaired systolic function, making the sample “representative of typical clinical populations.”
At baseline, patients were taking an average of seven medications. Nearly 40% did not adhere to the prescribed dosage of either an ACE inhibitor or a beta-blocker. Median sodium intake was almost twice as high as is recommended for HF patients, and depressive symptoms were evident in nearly 40%.
The study intervention included 18 2-hour group meetings over the course of a year. Patients were educated about medication adherence, sudden weight gain, sodium restriction, moderate physical activity, and stress management, and were given American Heart Association tip sheets concerning HF. The program also included counseling “to help patients develop mastery in problem-solving skills” as well as in five self-management skills: self-monitoring, environmental restructuring, elicitation of support from family and friends, cognitive restructuring, and the relaxation response.
The control group received the AHA tip sheets by mail, and discussed the material by phone with study counselors.
The intervention did not improve the primary end point, which was hospitalization for HF events or death. There were 163 events in the intervention group (40%) and 171 in the control group (41%), a nonsignificant difference. The annual event rate was 18% in the intervention group and 19% in the control group, also a nonsignificant difference.
Patients in both study groups had a mean of 0.7 HF hospitalizations. At the conclusion of the study, there were no differences between the two groups in 6-minute walk times, change in New York Heart Association class, heart rate, respiratory rate, blood pressure, or body mass index. There also were no differences in several measures of quality of life.
Moreover, nonadherence to prescribed ACE inhibitor or beta-blocker therapy had risen by 7% in both groups, Dr. Powell and her colleagues said (JAMA 2010;304:1331-8).
The researchers also performed a post hoc analysis of outcomes in nine subgroups of patients, categorizing patients by age, ethnicity, NYHA class, presence or absence of depressive symptoms, education level, annual income, and presence or absence of three or more comorbid conditions. Only one of these variables – a low annual income – correlated with improved outcomes in subjects who participated in the self-management intervention, compared with control subjects. This suggests that the intervention may be beneficial in low-income patients with HF, the investigators said.
HART was funded by the National Institutes of Health. An associate of Dr. Powell reported receiving research funding from Novartis after HART was concluded.