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

Abstract

Background Heart failure (HF) is increasing in prevalence and associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but non-adherence is high, ranging from 30–80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations. Trial Design HART evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite endpoints of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary endpoints included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was comprised of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline exam, patients were randomized to SM or education control, received 18 treatment contacts over one year, annual follow-ups, and 3-month phone calls to assess primary endpoints. SM 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/her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from the behavioral sciences.

From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases.

“…The value of articulating a hypothesized pathway, and collecting measurements for each of its links, lies in the ability to more precisely interpret the results of Phase III trials (Powell, Calvin, Mendes de Leon, Richardson, Grady, Flynn, Rucker-Whitaker, Janssen, et al, 2008). If the trial produces positive results, evidence specifically supporting each link of the chain strengthens the assertion that the observed effects were due to hypothesized pathways.…”

Effects of exercise training for heart failure with preserved ejection fraction: A systematic review and meta-analysis of comparative studies

“…After title and abstract screening, 2312 were excluded using predefined criteria. Twenty full-text papers were retrieved for assessment, 13 of which were excluded on full text review (a review article [23]), four exercise training studies in a mixed HFPEF and systolic HF populations that failed report of outcomes in HFPEF subgroup [24][25][26][27], an exercise training study in HFPEF with no relevant reported outcomes [28], five exercise training studies in a non-HFPEF population [29][30][31][32][33], and two abstracts for an included HFPEF training study for which we subsequently identified a full paper [34,35]. Seven papers were therefore included reporting the results of five distinct studies.…”

Stress Reduction in the Secondary Prevention of Cardiovascular Disease

“…Because double blinding in behavioral trials is generally not feasible, this was a single-blinded trial. 27 Subjects were assessed at baseline, month 3 and every 6 months after baseline for clinical events, blood pressure (BP), body mass index (BMI), and adherence. Lifestyle behaviors (diet, exercise, and substance use) and psychosocial distress factors were assessed annually.…”

“…27,49 The content was based on standard, published materials. 50,51 The instructors were professional health educators.…”