Multicomponent intervention for frail and pre‐frail older adults with acute cardiovascular conditions: The TARGET‐EFT randomized clinical trial

Abstract Background Hospitalization for cardiovascular disease (CVD) may be complicated by hospital‐acquired disability (HAD) and subsequently poor health‐related quality of life (HRQOL). While frailty has been shown to be a risk factor, it has yet to be studied as a therapeutic target to improve outcomes. Objectives This trial sought to determine the effects of an in‐hospital multicomponent intervention targeting physical weakness, cognitive impairment, malnutrition, and anemia on patient‐centered outcomes compared to usual care. Methods A single‐center parallel‐group randomized clinical trial was conducted in older patients with acute CVD and evidence of frailty or pre‐frailty as measured by the Essential Frailty Toolset (EFT). Patients were randomized to usual care or a multicomponent intervention. Outcomes were HRQOL (EQ‐5D‐5L score) and disability (Older Americans Resources and Services score) at 30 days post‐discharge and mood disturbances (Hospital Anxiety and Depression Scale) at discharge. Results The trial cohort consisted of 142 patients with a mean age of 79.5 years and 55% females. The primary diagnosis was heart failure in 29%, valvular heart disease in 28%, ischemic heart disease in 14%, arrhythmia in 11%, and other CVDs in 18%. The intervention improved HRQOL scores (coefficient 0.08; 95% CI 0.01, 0.15; p = 0.03) and mood scores (coefficient −1.95; 95% CI −3.82, −0.09; p = 0.04) but not disability scores (coefficient 0.18; 95% CI −1.44, 1.81; p = 0.82). There were no intervention‐related adverse events. Conclusion In frail older patients hospitalized for acute CVDs, an in‐hospital multicomponent intervention targeted to frailty was safe and led to modest yet clinically meaningful improvements in HRQOL and mental well‐being. The downstream impact of these effects on event‐free survival and functional status remains to be evaluated in future research, as does the generalizability to other healthcare systems. Clinical registration number: NCT04291690.