REGARDS and RURAL – Cohorts for Potential Dementia Questions

Suzanne Judd

Suzanne Judd �George Howard�Virginia Howard�Mary Cushman�Jennifer Manly�

REGARDS

REasons for Geographic And Racial Differences in Stroke

REGARDS�

• Central participant recruitment using mail and telephone
• Central computer-assisted telephone interview
• In-home evaluation for physical, venipuncture and EC Central laboratory and repository for serum and urine samples and ECG readings
• Central follow-up for detection of suspected stroke events
• Blinded adjudication of stroke events

REGARDS Study Design�Components of Telephone Interview

• Demographics (including SES measures)
• Major cardiovascular risk factors
• Lifestyle choices (smoking, alcohol, physical activity, etc)
• General Health and quality of life measures
• Access to care
• Depression
• Cognitive functioning screener

REGARDS Study Design�Self-Administered Packet

• Completed by the participant and returned to UAB by pre-addressed envelope
• Components
• Food Frequency Questionnaire (Block)
• “Where have you lived” Questionnaire
• Family history of stroke and heart disease
• “You and your doctor” Questionnaire

REGARDS Study Design�Lab Assay

• Conducted at the central lab at the University of Vermont (Mary Cushman)
• Components (partial list)
• Lipids, glucose, insulin, A1C, creatinine, urinary ACR, cystatin, CRP, cytokines, BNP, interleukins, GFAP
• Samples saved for planned case/control studies

• Serum • Cells (genetic studies)

• Plasma • Urine

REGARDS Study Design�Second in Home Visit (SSuRF)

• 2013-2016
• Goals
• 2^nd inhome visit
• Same lab and phenotype data as baseline
• Timed walk
• Chair stand
• Digit symbol substitution
• 2^nd longer telephone survey
• Baseline questions
• Lifespace
• AD8

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White American

Black American

N = 30,239

REGARDS Participants

Retention

Current Cognitive Outcomes

• Continuous test scores
• Word List Learning (WLL) and Delayed Recall (WLD)
• Administered every other year, scored automatically
• Semantic (Animal) Fluency and Phonemic (Letter F) Fluency
• Administered every other year, recorded and scored by trained individuals
• Six Item Screener (SIS)
• Administered annually, scored automatically
• Continuous factor scores
• Memory
• Language
• Overall cognition
• Cognitive Impairment
• Based on robust normative sample
• Can be applied to any of the above outcomes

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Cognitive Assessment Frequency

6 month follow up No cognitive tests

12 month follow up 6 item cognitive screener

18 month follow up Word List Learning and Animal Naming and MOCA

24 month follow up 6 item screener

30 month follow up No cognitive tests

36 month follow up 6 item screener

42 month follow up Word List Learning and Animal Naming and MOCA

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114 month follow up Word List Learning and Animal Naming and MOCA

120 month follow up 6 item screener

126 month follow up No cognitive tests

132 month follow up 6 item screener

138 month follow up Word List Learning and Animal Naming and MOCA

144 month follow up 6 item screener

Six Item Screener

Word List Learning

CESD and MOCA

Animal Naming

Letter F

Brain Health Study – In Home Visits to Identify MCI and Dementia in 1000 participants

NDI Process

• REGARDS links with the NDI annually
• NDI returns ICD10 codes for records that include
• underlying cause of death (the disease or injury that initiates the chain of events leading to death) 
• any mention of a condition or cause of death on the death certificate 
• Previous work in MESA indicated a PPV 73.2-92.6%
• Previous work in HRS included any dementia-related diagnosis (ICD-10 codes F00-F03, G30, G31.0-G31.1, and R54) or AD (ICD-10 codes F00 and G30). 

Table of NDI Values in Freeze

Not to be confused with this dataset that we share….

Alzheimer’s disease ICD 10 Codes �https://icd.who.int/browse10/2019/en#/F00-F09

REGARDS NDI

• We have received cause of death from NDI through 12/31/2020
• 10696 REGARDS participants have a cause of death in the NDI
• 1445 of those are coded as dementia
• 579 of the dementia deaths are coded as Alzheimer’s disease

Age

Race & Sex

Region

SES

Co-Morbid

Brain Related

REGARDS Renewal – Addressing Secular Trends in Stroke Mortality

From 1900 to 2010, United States life expectancy increased 65%, driven by an 80% decline in stroke mortality and a 68% decline in heart disease mortality. The remarkable gains in life expectancy were not equal by race, as gains were greater in non-Hispanic and Hispanic White Americans than in Black Americans.

Aim 1. To understand mechanisms of brain health disparities, including secular trends in cognitive function, stroke, and risk factors (established and novel) for stroke and VCID in the REGARDS-2 cohort. We will recruit and follow the REGARDS-2 cohort (n=20,000) to determine if recent increases in stroke and VCID are driven by changes in risk factor profile, and quantify the impact of changes in risk factor profile on widening racial disparities in stroke and VCID and their associated risk factors.�

Suzanne Judd �Vasan Ramachandran�

Urban Rural Disparities

• The youngest ages experience the greatest disparities between rural and urban communities
• 90% increase in all cause mortality
• 51% increase in CHD mortality
• 107% increase ion COPD mortality
• Risk Factor Disparities
• 131% increase smoking
• 93% increase in diabetes
• 127% greater risk in being uninsured

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Barriers to Research Participation

• Traditional cohort studies require a clinic that is typically near academic medical centers
• Taking a clinic to the participants can limit diagnostic testing
• Trust is challenging when face to face interaction is limited
• Exposure to medical research
• Research questions from the community may not be the same as investigators

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Bring the Clinic to the Participants

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RURAL Exam

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• Total exam time 3.5 hours
• MEU has lab, CT room, interview room, bathroom and reception space
• Physical
• Blood draw
• Spirometry
• mHealth (phone and fitbit)
• ECG, CT scan, echocardiogram
• Questionnaires (lifestyle, diet, neighborhood, stress, medications, health history, etc)

RURAL Objectives

• Recruit 4000-4600 aged 25-64 participants from 10 counties across Alabama, Mississippi, Louisiana, and Kentucky
• Build a mobile examination unit to provide a consistent evaluation for each participant
• Develop a genetic and biospecimen repository for future studies
• Engage each county through a community engagement coordinator who lives in the county throughout the study
• Retain participants for many years to come

How can I get involved?

• Write a manuscript
• Ancillary studies
• Add new exposure
• Add new outcome
• Analyze existing data through secondary data analysis
• Community based projects using existing infrastructure (advisory boards, focus groups, etc)
• https://www.theruralstudy.org/
• www.regardsstudy.org

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