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Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

Primary Purpose

Heart Failure; With Decompensation, Fragility

Status
Terminated
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Management Program
Sponsored by
Hospital Italiano de Buenos Aires
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure; With Decompensation

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 65 years or older
  2. Decompensated heart failure
  3. FRAIL scale equal to 3 or more points
  4. Permanent residence in the Metropolitan Area of Buenos Aires

Exclusion Criteria:

  1. Refusal to participate in the study
  2. Terminal oncology or cardiological disease
  3. Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis)
  4. Patients followed by geriatrics prior to admission
  5. Simultaneous participation in another research protocol

Sites / Locations

  • Rodrigo Aguirre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Management Program

Usual Care

Arm Description

Comanagement program (cardiological-geriatric) to carry out during hospitalization a comprehensive evaluation that allows to know the medical and socio-environmental needs of the patients to plan the required care at home and achieve an effective transition.

Usual care during hospitalizacion and discharge.

Outcomes

Primary Outcome Measures

Hospital admission
Number of hospital admission for any cause within 30 days

Secondary Outcome Measures

Mortality
Number of deaths from any cause within 30 days

Full Information

First Posted
November 19, 2020
Last Updated
December 7, 2022
Sponsor
Hospital Italiano de Buenos Aires
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1. Study Identification

Unique Protocol Identification Number
NCT04643184
Brief Title
Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
Official Title
Clinical Trial on Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment rate
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
November 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Italiano de Buenos Aires

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 controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.
Detailed Description
Randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure. Follow-up period 1 month. This protocol aims through a multidisciplinary vision, to carry out during hospitalization a comprehensive geriatric evaluation that allows to know the medical and socio-environmental needs of the patient to plan the required care at home and achieve an effective transition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure; With Decompensation, Fragility

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Co-management program (cardiological-geriatric) to carry out during hospitalization a comprehensive evaluation that allows to know the medical and socio-environmental needs of the patients to plan the required care at home and achieve an effective transition.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Management Program
Arm Type
Experimental
Arm Description
Comanagement program (cardiological-geriatric) to carry out during hospitalization a comprehensive evaluation that allows to know the medical and socio-environmental needs of the patients to plan the required care at home and achieve an effective transition.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care during hospitalizacion and discharge.
Intervention Type
Other
Intervention Name(s)
Management Program
Intervention Description
Joint management between the geriatric and cardiology team of the geriatric syndromes and heart failure. Education of the patient and their caregiver, preparing them for the transition of care.
Primary Outcome Measure Information:
Title
Hospital admission
Description
Number of hospital admission for any cause within 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Number of deaths from any cause within 30 days
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Prevalence of fragility
Description
The proportion of patients with a FRAIL scale equal to 3 or more points of the total number of patients hospitalized for heart failure
Time Frame
Admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 years or older Decompensated heart failure FRAIL scale equal to 3 or more points Permanent residence in the Metropolitan Area of Buenos Aires Exclusion Criteria: Refusal to participate in the study Terminal oncology or cardiological disease Reversible or treatable etiology heart failure (e.g. Takotsubo, acute cardiomyocarditis) Patients followed by geriatrics prior to admission Simultaneous participation in another research protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
César Belziti, MD
Organizational Affiliation
Hospital Italiano de Buenos Aires
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rodrigo Aguirre
City
Buenos Aires
State/Province
C.a.b.a
ZIP/Postal Code
C1199
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

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