A 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 endpoint of HF rehospitalization and cardiac death in this population.
Methods and Results—Patients (N=602, 66 ± 13 years old, 41% female, 51% systolic HF) were randomized to one of three 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 two follow-up phone calls, while the PLUS group received bi-weekly calls (mean 5.3±3.6, range 1-19) until the nurse judged the patient adequately trained. Over two years of follow-up, 35% of patients (n=211) experienced cardiac death or hospitalization for HF with no difference among the three groups in the proportion that experienced the combined clinical outcome (p=0.06). Although, patients in the LITE group had reduced cardiac mortality compared to patients in the control group over the two 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 control.
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 the outcome.
Clinical Trial Registration—www.ClinicalTrials.gov. Identifier: NCT00415545.
- Received May 2, 2013.
- Revision received April 26, 2014.
- Accepted May 7, 2014.