Integrated healthcare for frail patients with heart failure
INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
NA · Vestre Viken Hospital Trust · NCT06444321
This study tests whether a new team-based healthcare approach can help frail heart failure patients manage their symptoms better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vestre Viken Hospital Trust (other) |
| Locations | 1 site (Drammen, Akershus) |
| Trial ID | NCT06444321 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of integrated healthcare services on heart failure patients who are severely frail. It aims to establish interdisciplinary teams that will assess individual patient needs, conduct advance care planning, and develop tailored treatment plans. By focusing on coordinated follow-up across healthcare boundaries, the study seeks to improve symptom management and quality of life for this vulnerable population. The approach addresses a significant gap in current cardiovascular interventions, which often exclude frail patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are hospitalized with heart failure symptoms and have a Clinical Frailty Score of 5 or higher.
Not a fit: Patients with major co-morbidities, psychosocial issues, or those unable to understand Norwegian may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life and health outcomes for frail elderly patients suffering from heart failure.
How similar studies have performed: While integrated care approaches for frail patients are gaining attention, this specific study represents a novel effort to directly address the intersection of frailty and heart failure.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Drammen, Akershus
- Drammen Hospital — Drammen, Akershus, Norway (RECRUITING)
Study contacts
- Study coordinator: Øystein Fossdal, MD
- Email: oeyfos@vestreviken.no
- Phone: +4791367769
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Frailty, Frail Elderly Syndrome, Symptom, Behavioral, Utilization, Health Care, Quality of Life