INTEgRated Health CARE for Patients With Frailty and Heart Failure

Frailty, an aging-related syndrome of physiological decline characterized by marked vulnerability to adverse health outcomes, has attracted increasing attention in cardiology due to the growing elderly population with heart failure. Frail patients are mainly excluded from large cardiovascular intervention studies, and clinical trials addressing frailty and showing an impact on treatment on symptom burden, quality of life and /or outcome has been requested in recent guidelines and consensus documents. The INTEgrRated health CARE for patients with severe frailty and Heart Failure (INTERCARE-HF) is a proof-of-concept study that aims to evaluate the effect of integrated healthcare services for heart failure patients with a severe level of frailty by establishing interdisciplinary and coordinated follow-up teams across the healthcare boundaries. These teams will assess the patient's needs, goals, and risk areas, conduct advance care planning, and develop individualized treatment and follow-up plans. An open-label, non-randomized intervention study aims to recruit 20 patients and heart failure and a clinical Frailty Score (CSF) \>=5. A control-group (N=40) matched on age an clinical frailty scale score will be included. The overall hypothesis is that the intervention is feasible in routine clinical practice with favorable effects on quality of life, symptoms, caregiver distress, and healthcare service utilization.

NCT Number	NCT06444321
Lead Sponsor	Vestre Viken Hospital Trust Collaborators: Drammen municipality, University of Oslo, Oslo University Hospital
Conditions	Heart Failure, Frailty, Frail Elderly Syndrome, Symptom, Behavioral, Utilization, Health Care, Quality of Life
Enrollment	60 participants
Start Date	2024-06-06
Primary Completion	2025-06-01 (estimated)
Study Completion	2028-12-20 (estimated)
Updated on ClinicalTrials.gov	2024-06-13