Alzheimer's Disease and Precision Medicine Research Among Native People

NCT03448601 | Completed DMC

• 1 other identifier: 17-1627
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Precision Medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Willingness to Participate in Research Questionnaire

  Baseline

• Alzheimer's Disease (AD) Knowledge Scale

  Baseline

• Attitudes about Precision Medicine self-report survey

  Baseline

• Self-Administered Gerocognitive Exam (SAGE)

  Baseline

• Orthogonal Cultural Identification Scale

  Baseline

Study Arms (3)

Non-tailored control group

NO INTERVENTION

Participates will read the standard Alzheimer's disease and Precision Medicine brochure with standard text-based content NOT specifically tailored for AI/ANs.

Culturally tailored video intervention group

EXPERIMENTAL

Participants will view a short 5-minute culturally-tailored video.

Other: Culturally tailored video intervention group

Culturally tailored brochure intervention group

EXPERIMENTAL

Participants will read a culturally-tailored educational brochure on Alzheimer's disease and Precision Medicine.

Other: Culturally tailored brochure intervention group

Interventions

Culturally tailored brochure intervention group OTHER

Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.

Culturally tailored brochure intervention group

Culturally tailored video intervention group OTHER

Culturally-tailored Alzheimer's Disease and precision medicine educational video.

Culturally tailored video intervention group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Washington State University: collaborator
• Missouri Breaks Industries Research, Inc.: collaborator

Study Sites (1)

Missouri Breaks Industries Research, Inc.

Rapid City, South Dakota, 57701, United States

Location

Related Publications (2)

• 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.

  PMID: 18003939 BACKGROUND

• 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.

  PMID: 16571711 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Spero Manson, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 28, 2018
• Study Start: May 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)