Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
NCT Number: NCT05858034
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).
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Week 12
Change in physical performance battery scores - Minimum score 0 - Maximum score 12 - Higher scores indicate better lower extremity function
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
Time frame: Week 12
Reported adherence to activity and nutrition plan
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
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)
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".
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.
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.
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.
Time frame: Week 12
The fatigue/exhaustion questions will be administered using a paper survey
Contact information is provided by the study sponsor or research team.
Rica Abbott, MPH
CONTACT
Yolanda Belin, MS
CONTACT
Wake Forest University Health Sciences
Other
Identifying Challenges to Healthy Aging in Persons With HIV Age 50 and Older
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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