Follow-up Strategies for Fragile Patients With Decompensated Heart Failure

NCT04643184 | Terminated

• 1 other identifier: 5452
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; With Decompensation; Fragility

Outcome Measures

Primary Outcomes (1)

• Hospital admission

  Number of hospital admission for any cause within 30 days

  30 days

Secondary Outcomes (1)

• Mortality

  30 days

Other Outcomes (1)

• Prevalence of fragility

  Admission

Study Arms (2)

Management Program

EXPERIMENTAL

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.

Other: Management Program

Usual Care

NO INTERVENTION

Usual care during hospitalizacion and discharge.

Interventions

Management Program OTHER

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.

Management Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Rodrigo Aguirre

Buenos Aires, C.a.b.a, C1199, Argentina

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• César Belziti, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: December 2, 2020
• Primary Completion: November 9, 2021
• Study Completion: November 9, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)