INTEgRated Health CARE for Patients With Frailty and Heart Failure

NCT ID: NCT06444321

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2028-12-20

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

INTERCARE-HF

Intervention Type: BEHAVIORAL

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.

Matche control group

A matched control-group will be recruited from the ongoing IT-HEART RCT

Group Type: ACTIVE_COMPARATOR

INTERCARE-HF

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Matched control group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drammen municipality

UNKNOWN

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drammen Hospital

Drammen, Akershus, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Øystein Fossdal, MD

Role: CONTACT

oeyfos@vestreviken.no

+4791367769

John Munkhaugen, MD,MhD

Role: CONTACT

johmun@vestreviken.no

+4797524194

Facility Contacts

John Munkhaugen, MD, PhD

Role: primary

johmun@vestreviken.no

+4797524194

Øystein Fossdal, MD

Role: backup

Other Identifiers

678261

Identifier Type: -

Identifier Source: org_study_id