Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444321
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-30
Brief Title:
INTEgRated Health CARE for Patients With Frailty and Heart Failure
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
INTEgRated Health CARE for Patients With Frailty and Heart Failure INTERCARE-HF Evaluation of an Innovation Project
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERCARE-HF
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 patients 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 N40 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None