- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643184
Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
Clinical Trial on Follow-up Strategies for Fragile Patients With Decompensated Heart Failure
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
C.a.b.a
-
Buenos Aires, C.a.b.a, Argentina, C1199
- Rodrigo Aguirre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Management Program
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.
|
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.
|
No Intervention: Usual Care
Usual care during hospitalizacion and discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital admission
Time Frame: 30 days
|
Number of hospital admission for any cause within 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
Number of deaths from any cause within 30 days
|
30 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of fragility
Time Frame: Admission
|
The proportion of patients with a FRAIL scale equal to 3 or more points of the total number of patients hospitalized for heart failure
|
Admission
|
Collaborators and Investigators
Investigators
- Principal Investigator: César Belziti, MD, Hospital Italiano de Buenos Aires
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5452
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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