Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alzheimer's Disease and Precision Medicine Research Among Native People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448601
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : August 15, 2022
Sponsor:
Collaborators:
Washington State University
Missouri Breaks Industries Research, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Culturally tailored brochure intervention group Other: Culturally tailored video intervention group Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448601


Contacts
Layout table for location contacts
Contact: Erin Poole, MS 3037240177 erin.poole@cuanschutz.edu

Locations
Layout table for location information
United States, South Dakota
Missouri Breaks Industries Research, Inc. Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Marcia O'Leary, RN    605-791-1209    marcia.oleary@mbiri.com   
Sponsors and Collaborators
University of Colorado, Denver
Washington State University
Missouri Breaks Industries Research, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Spero Manson, PhD University of Colorado - Anschutz Medical Campus
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03448601    
Other Study ID Numbers: 17-1627
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: August 15, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Precision Medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders