Aging, HIV
Conditions
Keywords
human immunodeficiency virus, frailty, biomarkers of aging
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.
Interventions
OTHERCustomized 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.
OTHERCustomized 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.
Sponsors
Wake Forest University Health Sciences
Health Resources and Services Administration (HRSA)
National Institute on Aging (NIA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance scores | Week 12 | Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores | 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 |
| Percentage of Adherence with Plan | Week 12 | Reported adherence to activity and nutrition plan |
Countries
United States
Contacts
CONTACTYolanda Belin, MS
CONTACTRica Abbott, MPH
PRINCIPAL_INVESTIGATORCaryn G Morse, MD, MPH
Wake Forest University Health Sciences
Outcome results
None listed