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.
Age >18 years old
Admitted to hospital with heart failure with symptoms of decompensation including dyspnoea in NYHA class ≥ II, pulmonary congestion on chest x-ray and/or other signs like oedema or positive rales on auscultation and elevated NT-proBNP concentrations at screening
Clinical Frailty Score ≥5
Signed informed consent by patient and closest relatives* and expected cooperation according to the protocol, ICH/GCP and national/local regulations
Inability to comply with all study requirements, due to major co-morbidities or psychosocial issues, or a history of noncompliance, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures.
Not being able to understand Norwegian.
Permanent nursing home and estimated to stay alive for less than 6 months
Single group
INTERCARE-HF
BehavioralDevelpent of an individualized treatment and follow-up plan tailored to co-morbidities, risk areas, cognitive function and functional level as well as the patients' symptoms and needs.
Changes in symptom control and patient satisfaction
Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
Changes in health-related quality of life
Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores
Changes in caregiver distress
Changes in Relatives Stress Scale (RSS) scores
Total number of days lost due to unplanned hospital re-admissions during the follow-up
Differences in the percentage of days out of the total number of days lost due to unplanned hospital admissions
The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up
Differences in the percentage of days out of the number of days lost due to unplanned hospital admissions for i. heart failure, ii. kidney failure, dehydration or hyper/hypokalemia, iii. Falls and fractures
Total number of hospitalizations
Differences in the total number of hospitalizations during follow-up
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NorwayClick on the lead sponsor to view all of their trials.
Vestre Viken Hospital Trust
Lead sponsor
Drammen municipality
Collaborator
University of Oslo
Collaborator
Oslo University Hospital
Collaborator
