Alzheimer's Disease and Precision Medicine Research With American Indian and Alaska 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. Identifier: NCT03448601
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : August 22, 2018
Washington State University
University of Arizona
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This mixed-methods, multi-state study will develop and evaluate culturally tailored recruitment materials and test their effectiveness for a) engaging American Indian and Alaska Native participants in a culturally tailored recruitment and engagement module focused on Alzheimer's Disease and Precision Medicine (AD-PM); b) enhancing enrollment in AD-PM clinical trials; and c) improving knowledge and attitudes about AD and PM.

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

Detailed Description:
This study will use a mixed methods approach. The Investigators will focus on the American Indian and Alaska Native (AI/AN) population seen at the University of Arizona/Banner Health facilities in the Phoenix and Tucson areas. First, the recruitment strategies for enrolling AI/ANs will be examined in an implementation evaluation of an existing research program (All of Us) designed to assemble an observational cohort for the Precision Medicine Initiative. "All of Us" includes the procurement and storage of biological samples for health research integral to precision medicine. AI/ANs are underrepresented in Alzheimer's Disease (AD) and genetic research and this study will offer stakeholders valuable information on AI/AN perspectives on AD and preferred methods of communicating about AD, as well as developing a cohort of AI/AN people who are interested in AD and Precision Medicine (PM) research. To fulfill these goals, the Investigators will develop culturally tailored materials on AD and PM using qualitative methods, namely key informant interviews. In the final step, a randomized controlled trial will be conducted to compare the effectiveness of culturally tailored versus standard materials for enrolling AI/ANs into the AD-PM Module, and ultimately into a cohort that will be available for studies of AD and PM. Potential participants will be identified through the electronic health record or in person during outpatient clinical visits, emergency department visits, or inpatient hospitalizations. Enrollees in the All of Us Research Program will be asked whether they wish to participate in a 30 minute optional study on attitudes, knowledge, and willingness to participate in research, ethnic identity and cognition on AD and PM. The investigators estimate that 3,000 AI/ANs will agree and be randomized to receive a 3-4 minute presentation on AD and PM in a standard format (control), or to receive the same information presented in the culturally tailored format (intervention).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized in equal proportions either to receive a standard, non-tailored educational brochure on Alzheimer's Disease (AD), the value of precision medicine (PM), and the importance of research (control); or to receive a culturally tailored brochure with graphics and identical information and to view a digital story featuring personal narratives of AI/ANs (intervention).
Masking: Single (Participant)
Masking Description: Content of each arm will not be described to the participant.
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Non-tailored intervention group Other: Non-tailored intervention group
Alzheimer's Disease and precision medicine brochure

Experimental: Culturally tailored intervention group Other: Culturally tailored intervention group
Alzheimer's Disease and precision medicine enhanced 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

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • enrolled in the University of Arizona - Banner Health's All of Us program;
  • self-identify as American Indian or Alaska Native
  • deny visual impairments that would prevent them from reading the brochure or viewing the digital story
  • agree to link their All of Us data and biospecimens with data collected in the randomized control trial

Exclusion Criteria:

  • do not speak or read English

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 identifier (NCT number): NCT03448601

Contact: Laurie Moore, MPH 3037245897

Sponsors and Collaborators
University of Colorado, Denver
Washington State University
University of Arizona
Principal Investigator: Spero Manson, PhD University of Colorado - Anschutz Medical Campus

Responsible Party: University of Colorado, Denver Identifier: NCT03448601     History of Changes
Other Study ID Numbers: 17-1627
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders