- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03555318
Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.
Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Non-USA
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Barcelona, Non-USA, Spain, 08003
- Hospital del Mar, Parc de Salut Mar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Geriatrician + Cardiologist
Patients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician.
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Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.
After the geriatric assessment, measures to improve frailty will be started.
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Active Comparator: Cardiologist
Patients randomized to usual care (ambulatory follow up with a cardiologist).
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All patients will have an ambulatory visit with the cardiologist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with all-cause hospitalization within the defined time points
Time Frame: 1 year
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Number of participants with an all-cause hospitalization at 1 year follow-up
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with heart failure hospitalization within the defined time points
Time Frame: 1 year
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Number of participants with heart failure hospitalization at 1 year follow-up
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1 year
|
Number of participants dead within the defined time points
Time Frame: 1 year
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Number of participants dead at 1 year follow-up
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1 year
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Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
Time Frame: 1 year
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Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-applicable health related quality of life instrument specific to heart failure, within the defined time points.
The KCCQ ranges from 0 to 100, with 100 being the best state.
A change in 5 points at 1 year follow-up will be considered clinically relevant.
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1 year
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Change in functional capacity measured with the Barthel index within the defined time points
Time Frame: 1 year
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Change in functional capacity measured with the Barthel index at 1 year follow-up
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1 year
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Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
Time Frame: 1 year
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Change in the number of participants with more than 5 medications (polypharmacy) at 1 year follow-up
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1 year
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Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
Time Frame: 1 year
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Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) at 1 year follow-up
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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nuria Farre, MD, Institut Hospital del Mar d'Investigacions Mèdiques
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/7653/I
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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