INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Quality of Life; Frail Elderly Syndrome; Frailty; Symptom, Behavioral; Utilization, Health Care
• Intervention / Treatment: Behavioral: INTERCARE-HF

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Øystein Fossdal, MD; Phone Number: +4791367769; Email: oeyfos@vestreviken.no
• Study Contact Backup: Name: John Munkhaugen, MD,MhD; Phone Number: +4797524194; Email: johmun@vestreviken.no

Study Locations

• Norway
  • Viken
    • Drammen, Viken, Norway, 3004
      • Recruiting
      • Drammen Hospital
      • Contact: John Munkhaugen, MD, PhD; Phone Number: +4797524194; Email: johmun@vestreviken.no
      • Contact: Øystein Fossdal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Matched control group
Active Comparator: Matche control group; A matched control-group will be recruited from the ongoing IT-HEART RCT	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.; Other Names: Matched control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in caregiver distress	Changes in Relatives Stress Scale (RSS) scores	From baseline to weeks 6, 12, and 52
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
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
Total number of hospitalizations	Differences in the total number of hospitalizations during follow-up	From baseline to weeks 6, 12, and 52

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: University of Oslo; Oslo University Hospital; Drammen municipality

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 20, 2028

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Heart Failure; Frailty; Behavioral Symptoms
• Other Study ID Numbers: 678261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No