Frailty in Individuals With Advanced Heart Failure Part 2

May 28, 2024 updated by: Elyse Peterson, University of Southern California
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90077
        • Keck Hospital of USC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patients undergoing advanced heart failure intervention including LVAD implantation or heart transplantation
Heart Transplant
Recipients of a heart transplant.
Procedure: LVAD or Heart Transplant
Patients undergoing advanced heart failure intervention including LVAD implantation or heart transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Length of Stay
Time Frame: 1 to 500 days
Length of hospital stay after intervention
1 to 500 days
Rate of Readmission
Time Frame: 30 to 90 days
Rate of Readmission after initial hospital discharge
30 to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Elyse Peterson, OTD, OTR/L, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP-21-00687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Heart Failure

Clinical Trials on LVAD or Heart Transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe