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临床试验/NCT04791709
NCT04791709已完成不适用

Preventing Cognitive Decline in HIV-infected Latinos Through a Culturally Tailored Health Promotion Intervention (HOLA)

University of Miami2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Percentage of Participants Completing the Study

研究概览

简要总结

The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV.

详细描述

The purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older Latino adults living with HIV. It assesses the feasibility of running a health promotion program, led by a community health worker (CHW) intended to help prevent cognitive decline (loss of memory and/or functioning) through a culturally tailored health promotion intervention . Eligible participants will be Latino/Hispanic individuals 50 years of age or older, living with HIV, who may be at risk of developing chronic diseases such as dementia and Alzherimer's.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • are Latino (self-identified);
  • are age 50+;
  • are HIV infected but are virologically suppressed (viral load <200 copies/mL);
  • volunteer informed consent

排除标准

  • have diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's disease, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Telephone Interview for Cognitive Status (TICS) score less than or equal to 30;
  • have other conditions that could impact cognitive functioning or testing (e.g., legally blind or deaf), currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes.
  • have contraindications to physical activity outlined in the American College of Sports Medicine standards or severe medical illness that precludes them from safely participating in a health promotion intervention.
  • are unable to complete 10-meter walk test.
  • have plans to move outside of the Miami metropolitan area within the next 6 months or are not living in stable housing (e.g. group home).

结局指标

主要结局

Percentage of Participants Completing the Study

时间窗: 16 weeks

Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.

次要结局

  • Changes in Neurocognitive Impairment as Measured by the Trails Making Test(Baseline, 16 weeks)
  • Changes in Neurocognitive Impairment as Measured by the WAIS-IV Digit Span(Baseline, 16 weeks)
  • Changes in Physical Activity as Measured by the Global Physical Activity Questionnaire (GPAQ)(Baseline, 16 weeks)
  • Changes in Depression as Measured by the PHQ-9(Baseline, 16 weeks)
  • Changes in Anxiety as Measured by the GAD-7(Baseline, 16 weeks)
  • Changes in Psychosocial Functioning as Measured by the MSPSS(Baseline, 16 weeks)
  • Changes in Biomarkers of Cognition(Baseline, 16 weeks)
  • Changes in Biomarkers of Cognition Levels(Baseline, 16 weeks)
  • Changes in Adiponectin(Baseline, 16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Enrique Jimenez

Associate Professor

University of Miami

研究点 (2)

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