Alzheimer's Disease and Precision Medicine Research Among Native People

Alzheimer Disease Clinical Trial

Official title:

Specialized Centers of Excellence for Research on Minority Health and Health Disparities: Alzheimer's Disease and Precision Medicine Research: Addressing Gaps in Participation of American Indian and Alaska Native People

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03448601
• Other study ID #: 17-1627
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: Erin Poole, MS
• Phone: 3037240177
• Email: erin.poole[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project intends to address the gaps in Alzheimer's disease (AD) and precision medicine (PM) research in American Indian and Alaska Native (AI/AN) populations by comparing written and video-based materials for recruitment into AD and PM research, and by creating an AD-PM registry of AI/AN individuals who are willing to be contacted for future research opportunities.

Description:

This project intends to address the gaps in Alzheimer's disease (AD) and precision medicine (PM) research in American Indian and Alaska Native (AI/AN) populations by comparing written and video-based materials for recruitment into AD and PM research, and by creating an AD-PM registry of AI/AN individuals who are willing to be contacted for future research opportunities. The project will be a 3-arm RCT with a sample size of 501 AI/AN adults, aged 40 years and older. The RCT enables us to compare outcomes between groups to determine the effect of a tailored brochure and video compared to non-tailored, text-based recruitment materials, and assemble a large registry of AI/ANs with biospecimens and data from medical records for future AD research. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 501
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

Inclusion Criteria:

• self-identify as American Indian or Alaska Native
• able to speak, read, and understand English
• age 40 or older
• has cognitive and decisional capacity to consent

Exclusion Criteria:

• do not speak or read English
• vision or hearing impairments that would prevent reading a brochure or watching a video

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Missouri Breaks Industries Research, Inc.	Rapid City	South Dakota

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Missouri Breaks Industries Research, Inc., Washington State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AD-PM Module Completion	Completion of the AD-PM Module will be assessed by binary (yes, no) indicators of 1) providing consent for the Module; and 2) answering a question about enrolling in the AD-PM cohort and by a variable summarizing the total number of missing responses for the AD-PM module questions.	Baseline
Primary	Cohort Enrollment Questionnaire	Enrollment in the AD-PM Cohort will be assessed by binary (yes, no) indicators of agreeing to 1) join the Cohort, and 2) be contacted for participation in future studies.	Baseline
Secondary	Willingness to Participate in Research Questionnaire	Willingness to participate will be rated using a 4-point Likert scale (1=definitely would not, 2=probably would not; 3=probably would; 4=definitely would) after viewing 4 vignettes portraying hypothetical future projects related to Alzheimer's Disease, dementia, and Precision Medicine. Ranges for each vignette are 1 to 4 with higher scores indicating greater willingness to participate in research.	Baseline
Secondary	Alzheimer's Disease (AD) Knowledge Scale	30 true/false items on risk factors, assessment, diagnosis, symptoms, life impact, caregiving, treatment, and management. Range is 0 - 30 with higher scores indicating greater AD knowledge.	Baseline
Secondary	Attitudes about Precision Medicine self-report survey	Investigators will adapt a 44-item survey created by the National Institutes of Health to measure attitudes about the "All of Us" Alzheimer's Disease/Precision Medicine (AD/PM) Research Program to approximately 20 items specifically related to attitudes about PM rather than on All of Us more broadly. Items will be multiple choice (Definitely yes, Probably yes, Probably no, Definitely no) and binary (agree, disagree; yes, no). Ranges are not yet established as the survey is under development. Higher scores will indicate more positive attitudes about PM.	Baseline
Secondary	Self-Administered Gerocognitive Exam (SAGE)	To measure baseline cognitive function, scores from SAGE ranging from normal to mild cognitive impairment. Test scores range from 22 (normal) to 15 (mild cognitive impairment), with a score < 14 indicative of dementia and a score of = 17 considered normal.	Baseline
Secondary	Orthogonal Cultural Identification Scale	Cultural identity will be assessed from ratings of the degree to which participants identify with Native and White ways of life in family and community interactions. Items range from 1=not at all, 2=not much, 3=some, to 4=a lot with higher scores indicating higher cultural identification with the culture described.	Baseline