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

Primary Purpose

HIV, Aging

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Customized activity plan
Customized nutrition plan
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring human immunodeficiency virus, frailty, biomarkers of aging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atrium Health Wake Forest BaptistRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Activity Intervention

Nutrition Intervention

Arm Description

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

Development of a customized nutrition plan to address nutritional needs.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores
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
Percentage of Adherence with Plan
Reported adherence to activity and nutrition plan

Full Information

First Posted
April 26, 2023
Last Updated
June 30, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Health Resources and Services Administration (HRSA), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05858034
Brief Title
Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older
Official Title
Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Health Resources and Services Administration (HRSA), National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Aging
Keywords
human immunodeficiency virus, frailty, biomarkers of aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Persons with HIV age ≥50 years followed in the Atrium Health Wake Forest Baptist Health Infectious Diseases Specialty Clinic (AHWFB IDSC), The study will take place at in the outpatient clinics of Atrium Health Wake Forest Baptist Health IDSC in Winston-Salem, NC, High Point Medical Center in High Point, NC, and Lexington Memorial Hospital (Lexington, NC).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activity Intervention
Arm Type
Other
Arm Description
Customized selection of exercise and other community and online activity options to improve activity.
Arm Title
Nutrition Intervention
Arm Type
Other
Arm Description
Development of a customized nutrition plan to address nutritional needs.
Intervention Type
Other
Intervention Name(s)
Customized activity plan
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Customized nutrition plan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Performance scores
Description
Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores
Description
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
Time Frame
Week 12
Title
Percentage of Adherence with Plan
Description
Reported adherence to activity and nutrition plan
Time Frame
Week 12
Other Pre-specified Outcome Measures:
Title
electronic frailty index human immunodeficiency virus (eFI-HIV) scores
Description
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
Time Frame
Baseline
Title
Comprehensive geriatric screening (CGS) - Short Physical Performance Battery
Description
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)
Time Frame
Week 12
Title
Comprehensive geriatric screening (CGS) - Pepper Assessment Tool for Disability (PAT-D) Scores
Description
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".
Time Frame
Week 12
Title
Comprehensive geriatric screening (CGS) - brief cognitive screen (Mini-Cog) Scores
Description
(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.
Time Frame
Week 12
Title
depression Patient Health Questionnaire (PHQ-9) Scores
Description
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.
Time Frame
Week 12
Title
anxiety questionnaire - General Anxiety Disorder-7 (GAD-7) Scores
Description
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.
Time Frame
Week 12
Title
fatigue/exhaustion survey scores
Description
The fatigue/exhaustion questions will be administered using a paper survey
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yolanda Belin
Phone
(336) 716-7079
Email
ybelin@wakehealth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rica Abbott
Phone
(336) 716-7079
Email
rabbott@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caryn G Morse, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Health Wake Forest Baptist
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoland Belin
Phone
336-716-7079
Email
ybelin@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Caryn G Morse, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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