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| Name | Class |
|---|---|
| Drammen municipality | UNKNOWN |
| University of Oslo | OTHER |
| Oslo University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Matche control group | Active Comparator | A matched control-group will be recruited from the ongoing IT-HEART RCT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTERCARE-HF | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in symptom control and patient satisfaction | Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores | From baseline to weeks 6, 12, and 52 |
| Changes in health-related quality of life | Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores | From baseline to weeks 6, 12, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in caregiver distress | Changes in Relatives Stress Scale (RSS) scores | From baseline to weeks 6, 12, and 52 |
| Total number of days lost due to unplanned hospital re-admissions during the follow-up |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Øystein Fossdal, MD | Contact | +4791367769 | oeyfos@vestreviken.no | |
| John Munkhaugen, MD,MhD | Contact | +4797524194 | johmun@vestreviken.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drammen Hospital | Recruiting | Drammen | Akershus | 3004 | Norway |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000073496 | Frailty |
| D001526 | Behavioral Symptoms |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Open intervention study with a matched control-group
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Differences in the percentage of days out of the total number of days lost due to unplanned hospital admissions
| 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 | 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 | From baseline to weeks 6, 12, and 52 |
| Total number of hospitalizations | Differences in the total number of hospitalizations during follow-up | From baseline to weeks 6, 12, and 52 |
| D001519 | Behavior |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |