Skip to main content
Clinical Trials/NCT05858034
NCT05858034
Recruiting
N/A

Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older

Wake Forest University Health Sciences1 site in 1 country100 target enrollmentJune 27, 2023

Overview

Phase
N/A
Intervention
Customized activity plan
Conditions
HIV
Sponsor
Wake Forest University Health Sciences
Enrollment
100
Locations
1
Primary Endpoint
Physical Performance scores
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

The primary objective of this study is to identify and characterize frailty and pre-frailty in persons age 50 and older living with human immunodeficiency virus (HIV) followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinics (IDSC).

Detailed Description

The study will implement electronic medical record-based screening for frailty (eFI), further characterize frailty using comprehensive geriatric screening, and offer a customized activity and nutrition plan to a subset of participants. Participation in phlebotomy for research biomarkers of aging is optional. The study also seeks to validate the electronic medical record embedded electronic frailty index (eFI) for the prediction of adverse outcomes in aging persons with HIV, characterize the symptoms of pre-frailty and frailty in persons followed in the IDSC, and assess the acceptability and efficacy of a customized activity and nutrition intervention targeting frailty. The study will also correlate research biomarkers of aging with aging symptoms in a subset of participants.

Registry
clinicaltrials.gov
Start Date
June 27, 2023
End Date
August 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Person living with human immunodeficiency virus (HIV)
  • Age ≥50 years
  • Followed by the Atrium Health Wake Forest Baptist Infectious Diseases Specialty Clinic (IDSC)
  • Eligible for Ryan White Program
  • Able to provide informed consent
  • Pre-frail or frail by electronic frailty index (eFI)

Exclusion Criteria

  • Age \<50 years (study designed to characterize frailty in aging persons with HIV)
  • Unable to complete the required assessments or questionnaires

Arms & Interventions

Activity Intervention

Customized selection of exercise and other community and online activity options to improve activity.

Intervention: Customized activity plan

Nutrition Intervention

Development of a customized nutrition plan to address nutritional needs.

Intervention: Customized nutrition plan

Outcomes

Primary Outcomes

Physical Performance scores

Time Frame: Week 12

Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function

Secondary Outcomes

  • Percentage of Adherence with Plan(Week 12)
  • Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores(Week 12)

Study Sites (1)

Loading locations...

Similar Trials