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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Physical Performance scores [Срок оценки: Week 12]

Вторичные конечные точки (2)

• Quality of Life - 12-Item Short Form Health Survey (SF-12) Scores [Срок оценки: Week 12]
• Percentage of Adherence with Plan [Срок оценки: Week 12]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Age <50 years (study designed to characterize frailty in aging persons with HIV)
• Unable to complete the required assessments or questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Atrium Health Wake Forest Baptist — Winston-Salem

Идентификаторы

NCT: NCT05858034 · IRB00095309 · 3P30AG021332-20 · 6 H97HA46081-01-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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