Alzheimer's Disease and Precision Medicine Research Among Native People

October 30, 2023 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

501

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Missouri Breaks Industries Research, Inc.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Culturally tailored video intervention group
Participants will view a short 5-minute culturally-tailored video.
Other: Culturally tailored video intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational video.
Experimental: Culturally tailored brochure intervention group
Participants will read a culturally-tailored educational brochure on Alzheimer's disease and Precision Medicine.
Other: Culturally tailored brochure intervention group
Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AD-PM Module Completion
Time Frame: Baseline
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
Time Frame: Baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Willingness to Participate in Research Questionnaire
Time Frame: Baseline
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
Alzheimer's Disease (AD) Knowledge Scale
Time Frame: Baseline
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
Attitudes about Precision Medicine self-report survey
Time Frame: Baseline
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
Self-Administered Gerocognitive Exam (SAGE)
Time Frame: Baseline
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
Orthogonal Cultural Identification Scale
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Washington State University
Missouri Breaks Industries Research, Inc.

Investigators

  • Principal Investigator: Spero Manson, PhD, University of Colorado - Anschutz Medical Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 26, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1627

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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