MedTrace Logo

INTEgRated Health CARE for Patients With Frailty and Heart Failure

NCT06444321 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Drammen municipality

    collaborator UNKNOWN

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Vestre Viken Hospital Trust

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-06
Primary Completion
2025-06-01
Completion
2028-12-20

Countries

  • Norway

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444321 on ClinicalTrials.gov