Actively Recruiting
INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project
Led by Vestre Viken Hospital Trust · Updated on 2024-06-13
60
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
V
Vestre Viken Hospital Trust
Lead Sponsor
D
Drammen municipality
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating integrated healthcare services for patients with severe frailty and heart failure. This proof-of-concept study aims to assess the effect of coordinated, interdisciplinary follow-up teams that work across healthcare settings to address patients' needs, goals, and risks. The study responds to a need for clinical trials that focus on frail patients with heart failure, who are often excluded from large cardiovascular studies, with the goal of improving symptom burden, quality of life, and healthcare outcomes. The intervention involves developing a personalized treatment and follow-up plan tailored to each patient's co-morbidities, risk areas, cognitive and functional status, symptoms, and needs. An interdisciplinary team from the hospital and primary care collaborates on this plan. Close relatives are encouraged to participate. Follow-up is conducted at least monthly by nurses in the community through phone calls or home visits, with adjustments made as needed. A matched control group will be included from an ongoing randomized trial for comparison. Participants will be assessed at baseline, and then monitored at weeks 6, 12, and 52. Researchers will measure changes in symptom control, patient satisfaction, health-related quality of life, and caregiver distress. Hospitalization data, including unplanned readmissions and total hospital days lost, will also be collected. The study's duration includes follow-ups up to one year to evaluate the feasibility and impact of the integrated care approach on patients with severe frailty and heart failure.
CONDITIONS
Brief Title
INTEgRated Health CARE for Patients With Frailty and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years old
- Hospital admission with heart failure symptoms including dyspnoea in NYHA class 65 II, pulmonary congestion on chest x-ray, and/or oedema or positive rales
- Elevated NT-proBNP concentrations at screening
- Clinical Frailty Score 65
- Signed informed consent by patient and closest relatives with expected cooperation according to protocol, ICH/GCP, and regulations
You will not qualify if you...
- Inability to comply with study requirements due to major co-morbidities, psychosocial issues, or history of noncompliance
- Inability to understand Norwegian
- Permanent nursing home resident with expected survival less than 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 months
Participants receive a structured, person-centred and coordinated treatment and follow-up plan tailored to their co-morbidities, risk areas, cognitive function, functional level, symptoms, and needs. The plan is developed by an interdisciplinary team and followed up by nurses in the municipality through phone calls and/or home visits.
Follow-up after 1 week and then at least monthly visits via phone calls and/or home visits
Trial Site Locations
Total: 1 location
1
Drammen Hospital
Drammen, Akershus, Norway, 3004
Actively Recruiting
Research Team
Ø
Øystein Fossdal, MD
J
John Munkhaugen, MD,MhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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