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Brain Attack Surveillance in Corpus Christi--Cognitive (BASIC-Cognitive) (BASIC-C)

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ClinicalTrials.gov Identifier: NCT03403257
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Lewis Morgenstern, University of Michigan

Brief Summary:
The Mexican American population in the U.S. is rapidly growing and aging. This project seeks to determine the prevalence and outcomes of cognitive impairment and dementia in Mexican Americans. It also seeks solutions to help patients with cognitive impairment and dementia and their caregivers get the resources they need.

Condition or disease Intervention/treatment
Dementia Dementia Alzheimers Dementia, Vascular Dementia, Mixed Other: No interventions

Detailed Description:
Hispanic/Latinos will comprise more than 30% of the U.S. population by mid-century, and Mexican Americans account for the largest share of this growing segment of society. This proposal aims to use door-to-door surveillance in Nueces County, Texas, a non-immigrant, bi-ethnic community, to determine the prevalence and trajectory over time of cognitive impairment and dementia in Mexican Americans and non Hispanic whites. The study will elucidate the mechanisms that explain the hypothesized ethnic disparity in Alzheimer's disease and Alzheimer-related dementias by evaluating the roles of vascular disease risk factors, educational attainment and socio-economic status among others. This research will also delve deeply into the differences in informal caregiving for Mexican American and non Hispanic whites with cognitive impairment and dementia. Caregiver burden and mental and physical health of caregivers will be examined toward efforts to develop interventions that build resilience in caregivers. A novel ability of this population-based study is to examine community resources for both patients and caregivers, and how these provisions differ by ethnicity. Using a rigorous mixed methods approach the study will identify the gap between available resources and needs for those with cognitive impairment and dementia. In this way we will be well positioned to propose ethnic-specific testable interventions that promote mental and physical health for those with cognitive impairment and dementia, as well as for those family members who provide the care. This research will therefore lead to improved well-being, autonomy and outcomes among those with cognitive impairment and dementia and their caregivers. The investigative team members have conducted research in this community for 20 years and are experts in Mexican American culture and health, cognitive impairment and dementia, epidemiologic methods, community needs assessment and health behavior research. As the Mexican American population continues its tremendous growth and aging it is vitally important to better understand the prevalence and outcomes of cognitive impairment and dementia in this population, and to rapidly develop interventions that address the burden of these common conditions in Mexican American adults, families, and communities.

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Study Type : Observational
Estimated Enrollment : 776 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Attack Surveillance in Corpus Christi--Cognitive (BASIC-Cognitive)
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Group/Cohort Intervention/treatment
Subjects with cognitive impairment
Subjects with MoCA <26
Other: No interventions
No intervention

Caregivers
Primary caregivers of subjects
Other: No interventions
No intervention




Primary Outcome Measures :
  1. Prevalence of mild cognitive impairment and dementia in Mexican Americans and non Hispanic whites [ Time Frame: 2 year data collection ]
    Prevalence estimates

  2. Trajectory of cognitive function in Mexican Americans and non Hispanic whites [ Time Frame: 2 year follow-up after baseline ]
    Change in cognitive function among subjects entered at baseline

  3. Caregiver outcomes and changes over time [ Time Frame: 4 years ]
    Comparative caregiver outcomes among Mexican Americans and non Hispanic whites


Secondary Outcome Measures :
  1. Needs and community available resources for cognitive impairment [ Time Frame: 2 years ]
    An asset map and determination of needs



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-described
Sampling Method:   Probability Sample
Study Population
Residents of Nueces County, Texas
Criteria

Inclusion Criteria:

  1. >64 years of age
  2. MoCA < 26
  3. Nueces County resident at least 6 months a year
  4. English or Spanish speaking
  5. Community dwelling or nursing home

Exclusion Criteria: none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403257


Locations
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United States, Texas
Corpus Christi Nueces County Health District
Corpus Christi, Texas, United States, 78416
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Lewis Morgenstern, MD University of Michigan

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Responsible Party: Lewis Morgenstern, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03403257     History of Changes
Other Study ID Numbers: R01NS100687 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing plan conforms to NIH rules.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lewis Morgenstern, University of Michigan:
Caregiving
Hispanic
Mexican American
Epidemiology
Community
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases