Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older

March 27, 2024 updated by: Wake Forest University Health Sciences

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Caryn G Morse, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Activity Intervention
Customized selection of exercise and other community and online activity options to improve activity.
Other: Customized activity plan
Clients with identified challenges to successful aging (pre-frail or frail on screening) will be invited to develop an individualized activity plan to increase mobility, strength, and stamina. Plans will combine activities to improve strength (resistance training), balance (balance exercises), and stamina, and establish weekly goals. Resistance bands and pedometers will be provided. Progress will be measured by self-reported adherence to the activity plan at week 2, 4, 8, 12 and 24 (assessed by telephone at weeks 2, 4, 8 and in person at week 12 and 24). Depression questionnaire (PHQ-9), fatigue screen, exhaustion questions, and SF-12, a measure of health-related quality of life, will be administered at baseline, week 12 and 24.
Other: Nutrition Intervention
Development of a customized nutrition plan to address nutritional needs.
Other: Customized nutrition plan
Participants with nutritional needs will have the option of meeting with a nutritionist to develop a personalized nutritional plan with a goal of improving diet quality and optimizing caloric intake. Progress will be measured as above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores
Time Frame: Week 12
Change in quality of life as measured by SF-12 - Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Week 12
Percentage of Adherence with Plan
Time Frame: Week 12
Reported adherence to activity and nutrition plan
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
electronic frailty index human immunodeficiency virus (eFI-HIV) scores
Time Frame: Baseline
categorized as fit (eFI ≤0.10), pre-frail (0.10 < eFI≤0.21), and frail (eFI > 0.21) - the greater the score, the increased frailty
Baseline
Comprehensive geriatric screening (CGS) - Short Physical Performance Battery
Time Frame: Week 12
Short performance battery score (0-12) - The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three or four classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance)
Week 12
Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores
Time Frame: Week 12
self-reported mobility, basic and instrumental activities of daily living - Responses are made on a five-point Likert scale ranging from 1 ("usually did with no difficulty") to 5 ("unable to do") or a box can be checked that reads "usually did not do for other reasons".
Week 12
Comprehensive geriatric screening (CGS) - brief cognitive screen (Mini-Cog) Scores
Time Frame: Week 12
(Total Possible Score: 0-5) - A total score of 0, 1, or 2 indicates higher likelihood of clinically important cognitive impairment. A total score of 3, 4, or 5 indicates lower likelihood of dementia but does not rule out some degree of cognitive impairment.
Week 12
depression Patient Health Questionnaire (PHQ-9) Scores
Time Frame: Week 12
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Week 12
anxiety questionnaire - General Anxiety Disorder-7 (GAD-7) Scores
Time Frame: Week 12
Scoring GAD-7 Anxiety Severity. This is calculated by assigning scores - GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety.
Week 12
fatigue/exhaustion survey scores
Time Frame: Week 12
The fatigue/exhaustion questions will be administered using a paper survey
Week 12

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Aging (NIA)
Health Resources and Services Administration (HRSA)

Investigators

  • Principal Investigator: Caryn G Morse, MD, MPH, Wake Forest University Health Sciences

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)

June 27, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00095309
  • 3P30AG021332-20 (U.S. NIH Grant/Contract)
  • 6 H97HA46081-01-01 (Other Grant/Funding Number: Health Resources and Services Administration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data

IPD Sharing Time Frame

12 months after completion of the study.

IPD Sharing Access Criteria

Principal investigator permission and Institutional Review Board (IRB) review required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

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