A Randomized Clinical Trial of the Clinical Effects of Enhanced Heart Failure Monitoring Using a Computer-Based Telephonic Monitoring System in Older Minorities and Women

Abstract

Background Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure (HF). However, the use of these programs in settings with limited sources and among diverse population is not know. Thus the present study was designed to assess the impact of a computer-based home disease management program (Alere DayLink HF Monitoring System [HFMS]) on the clinical outcomes of Medicare beneficiaries with HF who were elderly, women, and non-white males who received the care from a community-based primary care practitioner. Methods and Results The Heart Failure Home Care (HFHC) trial was a multicenter, randomized, controlled trial of HFMS versus standard heart failure care (SC: enhanced patient education, education to clinicians, and follow-up).The primary study end point was treatment failure, defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment. Among patients rehospitalized for HF, length of hospital stay was also considered a primary end point. A total of 315 patients were randomized: 160 to HFMS and 155 to SC. Although the incidence of the primary outcome was somewhat higher in the SC arm (28.8% versus 21.2%, P = .15), the difference was not statistically different. The length of hospital stay was also similar in both groups. Conclusions Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly, women and non-Caucasian males and receive the care from a community-based primary care practitioner.