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Heart FailureINTERCARE-HFNCT06444321

INTEgRated Health CARE for Patients With Frailty and Heart Failure

A study testing INTERCARE-HF in people with Heart Failure and Frailty, run by Vestre Viken Hospital Trust at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Frailty, Frail Elderly Syndrome
What is being tested?
INTERCARE-HF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteNorway
Study dates
6 Jun 2024to 20 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Øystein Fossdal, MD contact

+4791367769

oeyfos@vestreviken.no

John Munkhaugen, MD,MhD contact

+4797524194

johmun@vestreviken.no

Norway1 site, 1 recruiting

  • Drammen Hospital

    Drammen, Akershus, 3004

    John Munkhaugen, MD, PhD, +4797524194, johmun@vestreviken.no

    Øystein Fossdal, MD

    Recruiting

Other trials in Norway

About this study

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

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.

Being tested
INTERCARE-HF
Medical subject headings
Heart Failure, Frailty, Behavioral Symptoms, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTERCARE-HFBehavioural

    Also called Matched control group

    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.

Study groups in NCT06444321
Study groupRoleWhat they receive
InterventionExperimentalA 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.
Receives: Behavioral: INTERCARE-HF
Matche control groupActive comparatorA matched control-group will be recruited from the ongoing IT-HEART RCT
Receives: Behavioral: INTERCARE-HF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in symptom control and patient satisfaction

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

    Measured: From baseline to weeks 6, 12, and 52

  2. Changes in health-related quality of life

    Between-group differences in Kansas City Cardiomyopathy Questionnaire 12 scores

    Measured: From baseline to weeks 6, 12, and 52

Secondary outcomes (4)

  1. Changes in caregiver distress

    Changes in Relatives Stress Scale (RSS) scores

    Measured: From baseline to weeks 6, 12, and 52

  2. Total number of days lost due to unplanned hospital re-admissions during the follow-up

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

    Measured: From baseline to weeks 6, 12, and 52

  3. 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

    Measured: From baseline to weeks 6, 12, and 52

  4. Total number of hospitalizations

    Differences in the total number of hospitalizations during follow-up

    Measured: From baseline to weeks 6, 12, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start6 Jun 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion20 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Open intervention study with a matched control-group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06444321
Sponsor's protocol ID
678261
Acronym
INTERCARE-HF
Status last verified
Jun 2024
First submitted
30 May 2024
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing INTERCARE-HF in people with Heart Failure and Frailty, run by Vestre Viken Hospital Trust at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Øystein Fossdal, MD (+4791367769, oeyfos@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in symptom control and patient satisfaction (time frame: From baseline to weeks 6, 12, and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06444321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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