INTEgRated Health CARE for Patients With Frailty and Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure; Symptom, Behavioral; Quality of Life; Utilization, Health Care; Frailty; Frail Elderly Syndrome
• Interventions: Behavioral: INTERCARE-HF

• Registration Number: NCT06444321
• Lead Sponsor: Vestre Viken Hospital Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Status Verified: 2024-06
• Study First Posted: 2024-06-05
• Study Start: 2024-06-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-06-01
• Study Completion: 2028-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Matche control group	INTERCARE-HF	A matched control-group will be recruited from the ongoing IT-HEART RCT
Intervention	INTERCARE-HF	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.

Primary Outcome Measures

Name	Time	Method
Changes in symptom control and patient satisfaction	From baseline to weeks 6, 12, and 52	Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores
Changes in health-related quality of life	From baseline to weeks 6, 12, and 52	Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores

Secondary Outcome Measures

Name	Time	Method
Total number of hospitalizations	From baseline to weeks 6, 12, and 52	Differences in the total number of hospitalizations during follow-up
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	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
Total number of days lost due to unplanned hospital re-admissions during the follow-up	From baseline to weeks 6, 12, and 52	Differences in the percentage of days out of the total number of days lost due to unplanned hospital admissions
Changes in caregiver distress	From baseline to weeks 6, 12, and 52	Changes in Relatives Stress Scale (RSS) scores

Trial Locations

Locations (1)

Drammen Hospital; 🇳🇴 Drammen, Viken, Norway