NCT03448601

Alzheimer's Disease and Precision Medicine Research Among Native People

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
OTHER	Culturally tailored brochure intervention group	Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.
OTHER	Culturally tailored video intervention group	Culturally-tailored Alzheimer's Disease and precision medicine educational video.

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2018-02-28
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States