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NCT Number: NCT06444321

INTEgRated Health CARE for Patients With Frailty and Heart Failure

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drammen Hospital

Drammen, Akershus, 3004, Norway

Location status: Recruiting

Location contact

John Munkhaugen, MD, PhD

CONTACT

[email protected]

+4797524194

Øystein Fossdal, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Matched control group

Primary outcomes

  1. Changes in symptom control and patient satisfaction

    Time frame: From baseline to weeks 6, 12, and 52

    Between-group differences in The Edmonton Symptom Assessment System revised (ESAS-r) scores

  2. Changes in health-related quality of life

    Time frame: From baseline to weeks 6, 12, and 52

    Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores

Secondary outcomes

  1. Changes in caregiver distress

    Time frame: From baseline to weeks 6, 12, and 52

    Changes in Relatives Stress Scale (RSS) scores

  2. 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

    Differences in the percentage of days out of the total number of days lost due to unplanned hospital admissions

  3. 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

    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

  4. Total number of hospitalizations

    Time frame: From baseline to weeks 6, 12, and 52

    Differences in the total number of hospitalizations during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

John Munkhaugen, MD,MhD

CONTACT

[email protected]

+4797524194

Øystein Fossdal, MD

CONTACT

[email protected]

+4791367769

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Drammen municipality
  • Oslo University Hospital
  • University of Oslo

Registry information

Official study title

INTEgRated Health CARE for Patients With Frailty and Heart Failure (INTERCARE-HF): Evaluation of an Innovation Project

Acronym: INTERCARE-HF

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Jun 5, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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