INTEgRated Health CARE for Patients With Frailty and Heart Failure

NCT06444321 | Recruiting

• 1 other identifier: 678261
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Changes in caregiver distress

  From baseline to weeks 6, 12, and 52

• Total number of days lost due to unplanned hospital re-admissions during the follow-up

  From baseline to weeks 6, 12, and 52

• The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up

  From baseline to weeks 6, 12, and 52

• Total number of hospitalizations

  From baseline to weeks 6, 12, and 52

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: INTERCARE-HF

Matche control group

ACTIVE COMPARATOR

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

Behavioral: INTERCARE-HF

Interventions

INTERCARE-HF 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.

Also known as: Matched control group

Intervention; Matche control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Drammen municipality: collaborator
• University of Oslo: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Drammen Hospital

Drammen, Akershus, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Heart Failure; Frailty; Behavioral Symptoms; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Øystein Fossdal, MD

CONTACT

+4791367769; oeyfos@vestreviken.no

John Munkhaugen, MD,MhD

CONTACT

+4797524194; johmun@vestreviken.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open intervention study with a matched control-group

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: June 6, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 20, 2028
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

NO (1)