Clinical trial NCT03555318: Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.
Official title: Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Frailty
Outcome
Hospitalization
Mortality
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Fundacion MAPFRE
First posted: 2018-06-13
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with all-cause hospitalization within the defined time points
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with heart failure hospitalization within the defined time points
timeFrame: 1 year
measure: Number of participants dead within the defined time points
timeFrame: 1 year
measure: Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
timeFrame: 1 year
measure: Change in functional capacity measured with the Barthel index within the defined time points
timeFrame: 1 year
measure: Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
timeFrame: 1 year
measure: Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar, Parc de Salut Mar
state: Non-USA
Study officials:
affiliation: Institut Hospital del Mar d'Investigacions Mèdiques
name: Nuria Farre, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.