Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas

BACKGROUND-: Patients with heart failure (HF) who live in rural areas have less access to cardiac services than patients in urban areas. We conducted a randomized, clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population. METHODS AND RESULTS-: Patients (n=602; age, 66±13 years; 41% female; 51% with systolic HF) were randomized to 1 of 3 groups: control (usual care), Fluid Watchers LITE, or Fluid Watchers PLUS. Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care. The LITE group received 2 follow-up phone calls, whereas the PLUS group received biweekly calls (mean, 5.3±3.6; range, 1-19) until the nurse judged the patient to be adequately trained. Over 2 years of follow-up, 35% of patients (n=211) experienced cardiac death or hospitalization for HF, with no difference among the 3 groups in the proportion who experienced the combined clinical outcome (P=0.06). Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up (7.5% and 17.7%, respectively; P=0.003), there was no significant difference in cardiac mortality between patients in the PLUS group and the control group. CONCLUSIONS-: A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF. Increasing the number of contacts between the patient and nurse did not significantly improve outcome. CLINICAL TRIAL REGISTRATION-: http://www.clinicaltrials.gov. Unique identifier: NCT00415545.