Frailty in Individuals With Advanced Heart Failure Part 2

NCT05127785 | Withdrawn

• 1 other identifier: UP-21-00687
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate how measures of frailty, assessed during occupational therapy (OT) evaluation and intervention impact decision for advanced heart failure (HF) therapies and postoperative outcomes.

Conditions

Heart Failure; Frailty

Outcome Measures

Primary Outcomes (2)

• Hospital Length of Stay

  Length of hospital stay after intervention

  1 to 500 days

• Rate of Readmission

  Rate of Readmission after initial hospital discharge

  30 to 90 days

Study Arms (3)

Medical Management

Patients deemed not candidates for advanced heart failure interventions.

Left Ventricular Assist Device (LVAD)

Recipients of a left ventricular assist device

Procedure: LVAD or Heart Transplant

Heart Transplant

Recipients of a heart transplant.

Procedure: LVAD or Heart Transplant

Interventions

LVAD or Heart Transplant PROCEDURE

Patients undergoing advanced heart failure intervention including LVAD implantation or heart transplantation

Heart Transplant; Left Ventricular Assist Device (LVAD)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with heart failure undergoing evaluation for advanced heart failure therapy.

You may qualify if:

• Individuals will be included in this study if they were evaluated for advanced heart failure therapies at Keck Hospital from 1/1/2019-6/30/2021. This will be determined through data from the electronic medical record.

You may not qualify if:

• Patients who did not receive an occupational therapy evaluation prior to advanced heart failure intervention decision.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90077, United States

Location

MeSH Terms

Conditions

Heart Failure; Frailty

Interventions

Heart Transplantation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Organ Transplantation; Transplantation

Study Officials

• Elyse Peterson, OTD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Occupational Therapy

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: November 9, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)