Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Completed · Not applicable
Conditions studied: Alzheimer Disease
In brief
This randomized non-inferiority study will evaluate self-directed scalable electronic health platform (eHealth) methods for communicating Alzheimer's gene and biomarker results compared to videoconference telehealth disclosure with healthcare providers, as well as characterize the impacts of learning this information on the participant.
Key facts
- Study ID
- NCT06459583
- Run by
- Banner Health
- People needed
- 681
- Starts
- 2024-10-10
- Expected to finish
- 2025-11-07
- Last updated by the study team
- 2026-01-14
Who can join
Age: 60 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Access to the internet and an internet-enabled device.
- Participant is able to provide informed consent as shown by correctly answering questions administered by the study coordinator during the electronic consenting process that assess understanding of consent form content.
- Participant is willing and has the ability to fully comply with study procedures defined in this protocol.
- Written and spoken fluency in the English.
- Participant agrees to undergo a blood draw for collection of a blood sample for future testing and repository storage.
You may not qualify if…
- Participant reports prior knowledge of APOE genotype.
- Lack of psychological readiness to receive AD gene and biomarker information as indicated by:
- obtaining a score of 10 or greater on the Patient Health Questionnaire - 9 (PHQ-9) AND/OR
- responding yes on any of the suicidal ideation questions extracted from the abbreviated Columbia Suicide Severity Scale (C-SSRS) or AD Specific Suicidality Questions.
- Presence of current major psychiatric illness, e.g., psychosis, bipolar disorder, PTSD
- Communication difficulties such as:
- Uncorrected or uncompensated hearing and/or vision impairment.
- Uncorrected or uncompensated speech defects.
Where it is running
- Accellacare Clinical Research Site 02 — Mt. Pleasant, South Carolina, United States
- Accellacare Clinical Research Site 01 — Bristol, Tennessee, United States
Full record on ClinicalTrials.gov
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