Drammen Hospital
Drammen, Akershus, 3004, Norway
Location status: Recruiting
NCT Number: NCT06444321
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Drammen, Akershus, 3004, Norway
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Matched control group
Time frame: From baseline to weeks 6, 12, and 52
Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
Time frame: From baseline to weeks 6, 12, and 52
Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores
Time frame: From baseline to weeks 6, 12, and 52
Changes in Relatives Stress Scale (RSS) scores
Time frame: From baseline to weeks 6, 12, and 52
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
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
Differences in the total number of hospitalizations during follow-up
Contact information is provided by the study sponsor or research team.
John Munkhaugen, MD,MhD
CONTACT
Øystein Fossdal, MD
CONTACT
Vestre Viken Hospital Trust
Other
INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
Acronym: INTERCARE-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06791967
Behavior, Behavioral Symptoms
Taipei, Taiwan
View Trial DetailsNCT07111585
Cardiovascular Diseases, Frailty
Incheon, South Korea
View Trial DetailsNCT05888688
Atrophy, Cardiovascular Diseases
Leicester, Leicestershire, United Kingdom
View Trial DetailsNCT06217640
Atrophy, Body Weight
Liverpool, Merseyside, United Kingdom
View Trial Details