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Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.

NCT ID: NCT03555318

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-11-05

Brief Summary

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Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.

Detailed Description

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Patients will be invited to participate on the day of hospital discharge. Once the informed consent has been signed, patients will be randomized with a 1: 1 ratio to conventional follow-up (cardiologist) or combined follow-up (ambulatory visit with cardiologist and geriatrics on the same day). Randomization will be stratified according to the presence or absence of criteria of frailty and ventricular function (cut-off 50%) to ensure that both groups are balanced. This stratification will be achieved by generating 4 different randomization lists. Frailty will be assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale. Randomization will be carried out by administrative staff independent of the study following a computer generated randomization scheme.The first visit will be made in less than 10 days after discharge from the hospital. Lawton and Barthel index and Pfeiffer test and quality of life test will be done in both groups.

The cost associated with care in the hospital is collected in each patient and therefore the total cost of the admissions, ambulatory visits and emergencies of each patient will be retrospectively evaluated.

In patients in the intervention arm the following areas will be evaluated: social sphere (Social and family evaluation scale of Gijón (abbreviated and modified) (Barcelona version), functional capacity (Barthel index and Lawton index), cognitive sphere (Pfeiffer test), emotional sphere (Geriatric Depression Scale Yesavage), nutritional status (Mini-Nutritional Assessment Short Form, plasma albumin), comorbidity (Charlson index) and the presence of geriatric syndromes (falls, polypharmacy, ulcers pressure, constipation, incontinence, insomnia.) Interdisciplinary interventions will be carried out in each of the areas evaluated.

Follow-up will be carried out at the heart failure clinic of the Cardiology Department at 3, 6 and 12 months. A clinical event evaluation committee will be appointed, consisting of 2 independent cardiologists, who will blindly adjudicate the events that occurred during the duration of the study.

Conditions

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Heart Failure

Keywords

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Heart failure Frailty Outcome Hospitalization Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Geriatrician + Cardiologist

Patients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician.

Group Type EXPERIMENTAL

Combined ambulatory visit

Intervention Type OTHER

Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.

Geriatric intervention

Intervention Type OTHER

After the geriatric assessment, measures to improve frailty will be started.

Cardiologist

Patients randomized to usual care (ambulatory follow up with a cardiologist).

Group Type ACTIVE_COMPARATOR

Ambulatory visit

Intervention Type OTHER

All patients will have an ambulatory visit with the cardiologist.

Interventions

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Ambulatory visit

All patients will have an ambulatory visit with the cardiologist.

Intervention Type OTHER

Combined ambulatory visit

Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.

Intervention Type OTHER

Geriatric intervention

After the geriatric assessment, measures to improve frailty will be started.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).

Exclusion Criteria

* Patients in palliative care.
* Patients with chronic pathologies with expected life expectancy \<1 year.
* Patients discharged to a skilled nursing facility
* Patients with heart valve replacement during index admission
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion MAPFRE

OTHER

Sponsor Role collaborator

Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuria Farre, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Hospital del Mar d'Investigacions Mèdiques

Locations

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Hospital del Mar, Parc de Salut Mar

Barcelona, Non-USA, Spain

Site Status

Countries

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Spain

References

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Luiso D, Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Belarte-Tornero LC, Valdivielso-More S, Morales RO, Vazquez O, Farre N. Quality of Life in Older Patients after a Heart Failure Hospitalization: Results from the SENECOR Study. J Clin Med. 2022 May 27;11(11):3035. doi: 10.3390/jcm11113035.

Reference Type DERIVED
PMID: 35683423 (View on PubMed)

Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Sole-Gonzalez E, Belarte-Tornero LC, Valdivielso-More S, Vazquez O, Farre N. Randomized Controlled Trial Comparing a Multidisciplinary Intervention by a Geriatrician and a Cardiologist to Usual Care after a Heart Failure Hospitalization in Older Patients: The SENECOR Study. J Clin Med. 2022 Mar 30;11(7):1932. doi: 10.3390/jcm11071932.

Reference Type DERIVED
PMID: 35407540 (View on PubMed)

Other Identifiers

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2017/7653/I

Identifier Type: -

Identifier Source: org_study_id