AzTrials
AzTrials

Alzheimer DiseaseNCT03448601

Alzheimer's Disease and Precision Medicine Research Among Native People

A study testing Culturally tailored brochure intervention group and Culturally tailored video intervention group in people with Alzheimer Disease, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Culturally tailored brochure intervention group and Culturally tailored video intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
523 participants
Where
1 siteUnited States
Study dates
1 May 2021to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Missouri Breaks Industries Research, Inc.

    Rapid City, South Dakota, 57701

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Culturally tailored brochure intervention group, Culturally tailored video intervention group
Keywords
Precision Medicine
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Culturally tailored brochure intervention groupOther

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

  • Culturally tailored video intervention groupOther

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

Study groups in NCT03448601
Study groupRoleWhat they receive
Non-tailored control groupNo interventionParticipates 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 groupExperimentalParticipants will view a short 5-minute culturally-tailored video.
Receives: Other: Culturally tailored video intervention group
Culturally tailored brochure intervention groupExperimentalParticipants will read a culturally-tailored educational brochure on Alzheimer's disease and Precision Medicine.
Receives: Other: Culturally tailored brochure intervention group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

Secondary outcomes (5)

  1. Willingness to Participate in Research Questionnaire

    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.

    Measured: Baseline

  2. Alzheimer's Disease (AD) Knowledge Scale

    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.

    Measured: Baseline

  3. Attitudes about Precision Medicine self-report survey

    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.

    Measured: Baseline

  4. Self-Administered Gerocognitive Exam (SAGE)

    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.

    Measured: Baseline

  5. Orthogonal Cultural Identification Scale

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start1 May 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
523 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448601
Sponsor's protocol ID
17-1627
Status last verified
Jun 2024
First submitted
9 Feb 2018
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18003939

  • 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.

    PubMed 16571711

Questions about this trial

What is this clinical trial studying?

A study testing Culturally tailored brochure intervention group and Culturally tailored video intervention group in people with Alzheimer Disease, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AD-PM Module Completion (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448601, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

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