Alzheimer's Disease and Precision Medicine Research Among Native People
NCT ID: NCT03448601
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
523 participants
INTERVENTIONAL
2021-05-01
2024-04-30
Brief Summary
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Detailed Description
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The AI/AN population is growing as a proportion of the total US population, and gains in life expectancy mean that the number of Native elders at risk of AD is rapidly increasing. Therefore, there is a need for research in this understudied group.
The study procedures are expected to take participants approximately 2-3 hours to finish. Participants will be asked to complete a pre-intervention self-report questionnaire and have their height, weight, and neck circumference measured. Next, they will be randomized to one of the 3-treatment arms. Participants allocated to the control condition will receive the standard brochure on AD and PM, with standard text-based content not specifically tailored for AI/ANs. Participants randomized to the intervention will either view a short culturally tailored video (5 minutes) or read a culturally tailored educational brochure. All brochures and video will contain the same base information on AD and PM. Participants will have as much time as they need to review the material. After each participant has finished reading the relevant brochure or viewing the video, they will be asked to complete post-intervention data collection that includes: 1) an ADRD knowledge questionnaire and 2) enrollment in the AD-PM Registry. If the participant chooses not to enroll in the AD-PM Registry, their participation in the study is complete. If the participant agrees to enroll in the registry, they will be asked to complete 3) the AD-PM Module, 4) biospecimen donation (blood, saliva, and urine samples), and 5) permission to access medical records. Participants who complete the AD-PM module and provide biospecimens but decline consent to access medical records will still be added to the registry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Non-tailored control group
Participates will read the standard Alzheimer's disease and Precision Medicine brochure with standard text-based content NOT specifically tailored for AI/ANs.
No interventions assigned to this group
Culturally tailored video intervention group
Participants will view a short 5-minute culturally-tailored video.
Culturally tailored video intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational video.
Culturally tailored brochure intervention group
Participants will read a culturally-tailored educational brochure on Alzheimer's disease and Precision Medicine.
Culturally tailored brochure intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.
Interventions
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Culturally tailored brochure intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.
Culturally tailored video intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational video.
Eligibility Criteria
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Inclusion Criteria
* able to speak, read, and understand English
* age 40 or older
* has cognitive and decisional capacity to consent
Exclusion Criteria
* vision or hearing impairments that would prevent reading a brochure or watching a video
40 Years
100 Years
ALL
Yes
Sponsors
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Washington State University
OTHER
Missouri Breaks Industries Research, Inc.
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Spero Manson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Missouri Breaks Industries Research, Inc.
Rapid City, South Dakota, United States
Countries
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References
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Mehta KM, Yaffe K, Perez-Stable EJ, Stewart A, Barnes D, Kurland BF, Miller BL. Race/ethnic differences in AD survival in US Alzheimer's Disease Centers. Neurology. 2008 Apr 1;70(14):1163-70. doi: 10.1212/01.wnl.0000285287.99923.3c. Epub 2007 Nov 14.
Castor ML, Smyser MS, Taualii MM, Park AN, Lawson SA, Forquera RA. A nationwide population-based study identifying health disparities between American Indians/Alaska Natives and the general populations living in select urban counties. Am J Public Health. 2006 Aug;96(8):1478-84. doi: 10.2105/AJPH.2004.053942. Epub 2006 Mar 29.
Other Identifiers
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17-1627
Identifier Type: -
Identifier Source: org_study_id
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