Clinical trial NCT06444321: INTEgRated Health CARE for Patients With Frailty and Heart Failure
Official title: INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Frailty
Frail Elderly Syndrome
Symptom, Behavioral
Utilization, Health Care
Quality of Life
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Drammen municipality
name: University of Oslo
name: Oslo University Hospital
First posted: 2024-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open intervention study with a matched control-group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in symptom control and patient satisfaction
timeFrame: From baseline to weeks 6, 12, and 52
measure: Changes in health-related quality of life
timeFrame: From baseline to weeks 6, 12, and 52
Secondary outcomes:
measure: Changes in caregiver distress
timeFrame: From baseline to weeks 6, 12, and 52
measure: Total number of days lost due to unplanned hospital re-admissions during the follow-up
timeFrame: From baseline to weeks 6, 12, and 52
measure: The number of days lost due to unplanned hospital re-admissions for specific diagnosis during the follow-up
timeFrame: From baseline to weeks 6, 12, and 52
measure: Total number of hospitalizations
timeFrame: From baseline to weeks 6, 12, and 52
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Drammen Hospital
state: Viken
Study officials:
References: