Clinical trial NCT03448601: Alzheimer's Disease and Precision Medicine Research Among Native People
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Precision Medicine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Washington State University
name: Missouri Breaks Industries Research, Inc.
First posted: 2018-02-28
Enrollment: 523
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in equal proportions either to receive 1) a standard, non-tailored educational brochure on Alzheimer's Disease (AD), the value of precision medicine (PM), and the importance of research (control); OR 2) to receive a culturally tailored brochure with graphics and identical information; OR 3) to view a digital story featuring personal narratives of AI/ANs (intervention).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: AD-PM Module Completion
timeFrame: Baseline
measure: Cohort Enrollment Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Willingness to Participate in Research Questionnaire
timeFrame: Baseline
measure: Alzheimer's Disease (AD) Knowledge Scale
timeFrame: Baseline
measure: Attitudes about Precision Medicine self-report survey
timeFrame: Baseline
measure: Self-Administered Gerocognitive Exam (SAGE)
timeFrame: Baseline
measure: Orthogonal Cultural Identification Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Rapid City
country: United States
facility: Missouri Breaks Industries Research, Inc.
state: South Dakota
Study officials:
affiliation: University of Colorado, Denver
name: Spero Manson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.