INTEgRated Health CARE for Patients With Frailty and Heart Failure

Heart Failure Clinical Trial

— INTERCARE-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444321
• Other study ID #: 678261
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: December 20, 2028

Study information

• Verified date: June 2024
• Source: Vestre Viken Hospital Trust
• Contact: Øystein Fossdal, MD
• Phone: +4791367769
• Email: oeyfos[@]vestreviken.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 20, 2028
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Behavioral Symptoms
• Frail Elderly Syndrome
• Frailty
• Heart Failure
• Quality of Life
• Symptom, Behavioral
• Utilization, Health Care

Intervention

Behavioral:
• INTERCARE-HF
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.

Locations

Country	Name	City	State
Norway	Drammen Hospital	Drammen	Viken

Sponsors (4)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Drammen municipality, Oslo University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in symptom control and patient satisfaction	Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores	From baseline to weeks 6, 12, and 52
Primary	Changes in health-related quality of life	Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores	From baseline to weeks 6, 12, and 52
Secondary	Changes in caregiver distress	Changes in Relatives Stress Scale (RSS) scores	From baseline to weeks 6, 12, and 52
Secondary	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	From baseline to weeks 6, 12, and 52
Secondary	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	From baseline to weeks 6, 12, and 52
Secondary	Total number of hospitalizations	Differences in the total number of hospitalizations during follow-up	From baseline to weeks 6, 12, and 52