Happy Older Latinos Are Active - Cognitive Decline

Cognitive Decline Clinical Trial

— HOLA-CD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04791709
• Other study ID #: 20201202
• Secondary ID: U54MD002266-14S1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• are Latino (self-identified);

• are age 50+;

• are HIV infected but are virologically suppressed (viral load <200 copies/mL);

• volunteer informed consent

Exclusion Criteria:

• 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 Mini Mental Status Exam score <24;

• 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).

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Behavioral:
• Happy Older Latinos are Active (HOLA)
HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	National Institute on Aging (NIA), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants completing the study	Feasibility of HOLA will be reported as the percentage of participants completing the post intervention assessment.	Up to 16 weeks
Secondary	Changes in neurocognitive impairment as measured by the Trails Making Test	Trail Making Test (TMT). Time to accurately complete Part A and Part B. The TMT measures neurocognitive functioning and consists of two parts; the first part requires participants to connect numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence. The test is scored by the time it takes to accurately complete each test. Increases in time correlate with greater impairment.	Baseline, 16 weeks
Secondary	Changes in neurocognitive impairment as measured by the WAIS-IV Digit Span	The Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) asks participants to repeat 2-9 numbers forward, backward and in ascending order to assess attention, processing speed, and working memory. The scores are summarized with lower scores indicating increased cognitive impairment.	Baseline, 16 weeks
Secondary	Changes in physical activity as measured by the GPAQ	The Global Physical Activity Questionnaire (GPAQ) is a summed score of recreational and transport activities in units of minutes for moderate-to-vigorous physical activity levels during a typical week will be calculated using the World Health Organization (WHO) scoring guide.	Baseline, 16 weeks
Secondary	Changes in depression as measured by the PHQ-9	The Patient Health Questionnaire (PHQ-9) is a 9 item questionnaire that measures depression severity. The total score ranges from 0-27 with higher scores indicating more severe depression.	Baseline, 16 weeks
Secondary	Changes in anxiety as measured by the GAD-7	The Generalized Anxiety Disorder (GAD-7) is a 7 item questionnaire that measures anxiety severity. The total score ranges from 0-21 with higher scores indicating more severe anxiety.	Baseline, 16 weeks
Secondary	Changes in psychosocial functioning as measured by the MSPSS	The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12 item questionnaire that measures perceived social support. The total score ranges from 1-84 with higher scores indicating more perceived social support.	Baseline, 16 weeks
Secondary	Changes in biomarkers of cognition	Biomarkers of cognition including interleukin-15, brain derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEG-F) reported in pg/ml will be assessed from blood samples.	Baseline, 16 weeks
Secondary	Changes in biomarkers of cognition levels	Biomarkers of cognition levels including irisin and insulin like growth factor (IGF-1) reported in ng/ml will be assessed from blood samples.	Baseline, 16 weeks
Secondary	Changes in adiponectin	Adiponectin will be assessed from blood samples.	Baseline, 16 weeks