To assess the feasibility and effectiveness of a low-complexity, low-cost model of caregiver education in primary care, targeted to reduce hospitalizations of heart failure patients.
A cluster-randomized, controlled, open trial was proposed to general practitioners, who were invited to identify patients with heart failure, exclusively managed at home and continuously attended by a caregiver. Participating general practitioners were then randomized to: usual treatment; caregiver education (educational session for recognizing early symptoms/signs of heart failure, with recording in a diary of a series of patient parameters, including body weight, blood pressure, heart rate). The patients were observed at baseline and during a 12-month follow-up.
Three hundred and thirteen patients were enrolled (163 in the intervention, 150 in the usual care group), 63% women, mean age 85.3 ± 7.7 years. At the end of the 12-month follow-up, a trend towards a lower incidence of hospitalizations was observed in the intervention group (hazard ratio 0.73; 95% CI 0.53–1.01 P = 0.061). Subgroup analysis showed that for patients with persistent/permanent atrial fibrillation, age less than 90 years or Barthel score equal to or greater than 50 a significant lower hospital admission rate occurred in the intervention group (hazard ratio 0.63; 95% CI 0.39–0.99; P = 0.048, hazard ratio 0.66; 95% CI 0.45–0.97; P = 0.036 and hazard ratio 0.61; 95% CI 0.41–0.89; P = 0.011, respectively).
Caregivers training for early recognition of symptoms/signs of worsening heart failure may be effective in reducing hospitalizations, although the benefit was evident only in specific patient subgroups (with persistent/permanent atrial fibrillation, age <90 years or Barthel score ≥ 50), with only a positive trend in the whole cohort.
ClinicalTrials.gov Identifier: NCT03389841.
aFamily Medicine Teaching Unit, University of Modena and Reggio Emilia, Modena
bItalian College of General Practitioners and Primary Care, Florence
cStatistics Unit, Department of Diagnostics, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena
dClinical Governance Unit, Local Health Authority, Modena
eCardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena University Hospital, Modena, Italy
Correspondence to Giuseppe Boriani, Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena University Hospital, Modena, Italy E-mail: firstname.lastname@example.org
Received 20 March, 2018
Accepted 13 September, 2018
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