INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ Although we preferably will recruit both patients and their relatives, participation from the next-of-kin will not be an exclusion criterium.

Locations
Other Locations
Norway
Drammen Hospital
RECRUITING
Drammen
Contact Information
Primary
Øystein Fossdal, MD
oeyfos@vestreviken.no
+4791367769
Backup
John Munkhaugen, MD,MhD
johmun@vestreviken.no
+4797524194
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2028-12-20
Participants
Target number of participants: 60
Treatments
Experimental: Intervention
A structured, person-centred and coordinated treatment and follow-up plan tailored to co-morbidities, risk areas, cognitive function and functional level, and the patients' symptoms and needs will be developed by an interdisciplinary team from the hospital and the primary care service. The closest relatives were encouraged to participate. The plan will be followed-up and evetually adjusted after one week and then at least monthly by nurses in the municipality through phone calls and /or home visits. A detailed description will be manualized in a handbook.
Active_comparator: Matche control group
A matched control-group will be recruited from the ongoing IT-HEART RCT
Related Therapeutic Areas
Sponsors
Collaborators: University of Oslo, Drammen municipality, Oslo University Hospital
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov