INTEgRated Health CARE for Patients With Frailty and Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: INTERCARE-HF.
- Who it may be relevant to
- Registry conditions: Heart Failure, Frailty, Frail Elderly Syndrome, Symptom, Behavioral. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
Overview
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.
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.
Primary outcome measures
- Changes in symptom control and patient satisfaction [Time frame: From baseline to weeks 6, 12, and 52]
- Changes in health-related quality of life [Time frame: From baseline to weeks 6, 12, and 52]
Secondary outcome measures (4)
- Changes in caregiver distress [Time frame: From baseline to weeks 6, 12, and 52]
- Total number of days lost due to unplanned hospital re-admissions during the follow-up [Time frame: 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 [Time frame: From baseline to weeks 6, 12, and 52]
- Total number of hospitalizations [Time frame: From baseline to weeks 6, 12, and 52]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Drammen Hospital — Drammen
Identifiers
NCT: NCT06444321 · 678261