Actively Recruiting
INTEgRated Health CARE for Patients With Frailty and Heart Failure
Led by Vestre Viken Hospital Trust · Updated on 2024-06-13
60
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
V
Vestre Viken Hospital Trust
Lead Sponsor
D
Drammen municipality
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
INTEgRated Health CARE for Patients With Frailty and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years old
- Hospital admission with heart failure symptoms including dyspnoea in NYHA class 65 II, pulmonary congestion on chest x-ray, or other signs like oedema or positive rales
- Elevated NT-proBNP concentrations at screening
- Clinical Frailty Score 65
- Signed informed consent by patient and closest relatives and expected cooperation according to protocol and regulations
You will not qualify if you...
- Inability to comply with study requirements due to major co-morbidities, psychosocial issues, or history of noncompliance
- Unable to understand Norwegian
- Permanent nursing home resident with estimated life expectancy less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Drammen Hospital
Drammen, Akershus, Norway, 3004
Actively Recruiting
Research Team
Ø
Øystein Fossdal, MD
CONTACT
J
John Munkhaugen, MD,MhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here