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.

Keywords: cardiovascular disease; clinical trial; frailty; intervention; rehabilitation.