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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ambulatory visit
Combined ambulatory visit
Geriatric intervention
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Frailty, Outcome, Hospitalization, Mortality

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital del Mar, Parc de Salut Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Geriatrician + Cardiologist

Cardiologist

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of participants with all-cause hospitalization within the defined time points
Number of participants with an all-cause hospitalization at 1 year follow-up

Secondary Outcome Measures

Number of participants with heart failure hospitalization within the defined time points
Number of participants with heart failure hospitalization at 1 year follow-up
Number of participants dead within the defined time points
Number of participants dead at 1 year follow-up
Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
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.
Change in functional capacity measured with the Barthel index within the defined time points
Change in functional capacity measured with the Barthel index at 1 year follow-up
Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
Change in the number of participants with more than 5 medications (polypharmacy) at 1 year follow-up
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) at 1 year follow-up

Full Information

First Posted
May 7, 2018
Last Updated
November 5, 2020
Sponsor
Parc de Salut Mar
Collaborators
Fundacion MAPFRE
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1. Study Identification

Unique Protocol Identification Number
NCT03555318
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
Collaborators
Fundacion MAPFRE

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Frailty, Outcome, Hospitalization, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Geriatrician + Cardiologist
Arm Type
Experimental
Arm Description
Patients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician.
Arm Title
Cardiologist
Arm Type
Active Comparator
Arm Description
Patients randomized to usual care (ambulatory follow up with a cardiologist).
Intervention Type
Other
Intervention Name(s)
Ambulatory visit
Intervention Description
All patients will have an ambulatory visit with the cardiologist.
Intervention Type
Other
Intervention Name(s)
Combined ambulatory visit
Intervention Description
Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.
Intervention Type
Other
Intervention Name(s)
Geriatric intervention
Intervention Description
After the geriatric assessment, measures to improve frailty will be started.
Primary Outcome Measure Information:
Title
Number of participants with all-cause hospitalization within the defined time points
Description
Number of participants with an all-cause hospitalization at 1 year follow-up
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of participants with heart failure hospitalization within the defined time points
Description
Number of participants with heart failure hospitalization at 1 year follow-up
Time Frame
1 year
Title
Number of participants dead within the defined time points
Description
Number of participants dead at 1 year follow-up
Time Frame
1 year
Title
Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
Description
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.
Time Frame
1 year
Title
Change in functional capacity measured with the Barthel index within the defined time points
Description
Change in functional capacity measured with the Barthel index at 1 year follow-up
Time Frame
1 year
Title
Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
Description
Change in the number of participants with more than 5 medications (polypharmacy) at 1 year follow-up
Time Frame
1 year
Title
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
Description
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) at 1 year follow-up
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuria Farre, MD
Organizational Affiliation
Institut Hospital del Mar d'Investigacions Mèdiques
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar, Parc de Salut Mar
City
Barcelona
State/Province
Non-USA
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35683423
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.
Results Reference
derived
PubMed Identifier
35407540
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.
Results Reference
derived

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

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