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Randomized, Controlled Trial to Improve Self-Care in Patients With Heart Failure Living in Rural Areas
Study Questions:
What is the impact of a face-to-face education intervention in patients living in rural areas and diagnosed with either heart failure with reduced ejection fraction (HFrEF) or heart failure with preserved ejection fraction (HFpEF) on the composite endpoint of HF hospitalization and cardiac death?
Methods:
REMOTE-HF (Rural Education to Improve Outcomes in Heart Failure) was a multicenter, randomized, controlled trial of patients recruited from rural regions of California, Kentucky, and Nevada. Eligible patients must have been hospitalized for HF within the past 6 months; patients with psychiatric illness were excluded. Patients were randomized to one of three groups: control (usual care), Fluid Watchers LITE, or Fluid Watchers PLUS. Patients in the two experimental arms received an approximately 50-minute face-to-face education session delivered by a nurse; the focus of the session was on all aspects of self-care, especially patients’ dry weight, monitoring of daily weights, and recognition of early signs of fluid overload. The LITE group received two follow-up phone calls; the PLUS group received biweekly calls, which were continued until the nurse determined the patient was adequately trained. Physicians were blinded to patient assignment. The endpoint was a composite of HF re-hospitalization and cardiac death. The nine-item European HF Self-Care Behavior Scale was used to measure HF-related self-care.
Results:
A total of 602 patients had data available for the analysis of clinical outcomes at 2 years (98% of the enrolled sample). Although both the LITE and PLUS groups had significantly better self-care scores than the control group (p < 0.05) at 3 and 12 months, this was no longer sustained at 24 months. Over 2 years of follow-up, 35% of patients experienced either cardiac death or hospitalization for HF; groups did not differ significantly for the combined clinical outcome. Cardiac mortality, however, was significantly different among the groups (p = 0.008) with the proportion of patients who experienced a cardiac death significantly less in the LITE group (7.5%) compared with the control group (17.7%; p = 0.003). The difference in cardiac deaths between the LITE and PLUS groups was not significant.
Conclusions:
A nurse-led face-to-face primarily self-care educational intervention delivered to patients living in rural areas with HFpEF or HFrEF and with a recent hospitalization did not significantly decrease the combined endpoint of cardiac death or hospitalization for HF. Cardiac mortality, however, was significantly decreased in one of the intervention groups (Fluid Watchers LITE).
Perspective:
This is an important study that evaluates the impact of an educational intervention delivered in rural settings. Although the combined endpoint was not affected by the intervention, cardiac mortality was decreased in one of the intervention groups. As the authors suggest, ‘An intervention such as the one in this trial that is focused specifically on preventing HF exacerbations is best evaluated using the specific outcome most germane to the intervention, which is cardiac death.’ This is a legitimate point, and I would not discount the value of this important educational intervention that could improve self-care in a potentially vulnerable population.
Keywords: Kentucky, Follow-Up Studies, Self Care, Vulnerable Populations, California, Heart Failure, Nevada, Nurses, Hospitalization
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