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.|
|ClinicalTrials.gov Identifier: NCT03448601|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Other: Non-tailored intervention group Other: Culturally tailored intervention group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|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 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|
|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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Laurie Moore, MPHfirstname.lastname@example.org|
|Principal Investigator:||Spero Manson, PhD||University of Colorado - Anschutz Medical Campus|