Frailty in Individuals With Advanced Heart Failure Part 2
Sponsor
University of Southern California (Other)
Overall Status
Recruiting
CT.gov ID
NCT05127785
Collaborator
(none)
400
1
12.7
31.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
400 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Frailty in Individuals With Advanced Heart Failure Part 2
Actual Study Start Date
:
Nov 9, 2021
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Hospital Length of Stay [1 to 500 days]
Length of hospital stay after intervention
- Rate of Readmission [30 to 90 days]
Rate of Readmission after initial hospital discharge
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Keck Hospital of USC | Los Angeles | California | United States | 90077 |
Sponsors and Collaborators
- University of Southern California
Investigators
- Principal Investigator: Elyse Peterson, OTD, OTR/L, University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Elyse Peterson,
Associate Professor of Clinical Occupational Therapy,
University of Southern California
ClinicalTrials.gov Identifier:
NCT05127785
Other Study ID Numbers:
- UP-21-00687
First Posted:
Nov 19, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: