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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Develpent 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.
Drammen Hospital
Drammen, Akershus, Norway
RECRUITINGChanges in symptom control and patient satisfaction
Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
Time frame: From baseline to weeks 6, 12, and 52
Changes in health-related quality of life
Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores
Time frame: From baseline to weeks 6, 12, and 52
Changes in caregiver distress
Changes in Relatives Stress Scale (RSS) scores
Time frame: From baseline to weeks 6, 12, and 52
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
Time frame: From baseline to weeks 6, 12, and 52
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
Time frame: From baseline to weeks 6, 12, and 52
Total number of hospitalizations
Differences in the total number of hospitalizations during follow-up
Time frame: From baseline to weeks 6, 12, and 52
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