NCT06444321Recruiting
INTEgRated Health CARE for Patients With Frailty and Heart Failure
INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
Source: ClinicalTrials.gov · Last updated 13 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 30 May 2024
- Start date
- 6 Jun 2024
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Vestre Viken Hospital Trust
- Diseases
- Heart failure
- NCT number
- NCT06444321
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 6 Jun 2024 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Not being able to understand Norwegian.
- Permanent nursing home and estimated to stay alive for less than 6 months
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Drammen hospital Coordinator of this site? Confirm its status | Drammen | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.