Identifying Challenges to Healthy Aging in Persons With Human Immunodeficiency Virus (HIV) Age 50 and Older
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Customized activity plan, Customized nutrition plan.
- Who it may be relevant to
- Registry conditions: HIV, Aging. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older
Overview
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
- 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 - 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.
Primary outcome measures
- Physical Performance scores [Time frame: Week 12]
Secondary outcome measures (2)
- Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores [Time frame: Week 12]
- Percentage of Adherence with Plan [Time frame: Week 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Atrium Health Wake Forest Baptist — Winston-Salem
Identifiers
NCT: NCT05858034 · IRB00095309 · 3P30AG021332-20 · 6 H97HA46081-01-01