Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results

NCT06459583 | Completed

• 2 other identifiers: API-0001R01AG058468
• Study Type: interventional
• Target: 681
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

APOE

Outcome Measures

Primary Outcomes (3)

• Anxiety as measured by the PROMIS Anxiety scale

  Anxiety scale

  T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

• Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale

  Knowledge of Genetic Disease scale

  T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

• Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale

  Disease-specific distress scale

  T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)

Secondary Outcomes (6)

• Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)

  0-7 days, 6 weeks, 6 months

• Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale

  6 months

• Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study

  0-7 days, 6 weeks, 6 months

• Impact of disclosure as measured by the 16-item IGT-AD scale

  0-7 days, 6 weeks, 6 months

• Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument

  6 months

Study Arms (2)

eHealth platform

EXPERIMENTAL

The eHealth platform consists of the self-directed web-portal (ADWebPortal) and chatbot (ADChatbot) to receive their Alzheimer's-related test results. Participants randomized to this arm can switch between the two or schedule a virtual appointment with a healthcare provider.

Other: eHealth Platform

Videoconference telehealth

ACTIVE COMPARATOR

The videoconference telehealth platform consists of remote visit(s) with a healthcare provider to receive their Alzheimer's-related test results.

Other: Videoconference Telehealth Platform

Interventions

eHealth Platform OTHER

The eHealth Platform consists of the ADWebPortal and ADChatbot for receiving Alzheimer's-related test results

eHealth platform

Videoconference Telehealth Platform OTHER

Participants will have a video telehealth visit with a healthcare provider to receive Alzheimer's-related test results

Videoconference telehealth

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Banner Health: lead
• National Institute on Aging (NIA): collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

Accellacare Clinical Research Site 02

Mt. Pleasant, South Carolina, 29464, United States

Location

Accellacare Clinical Research Site 01

Bristol, Tennessee, 37620, United States

Location

Related Publications (1)

• Erickson CM, Langlois CM, Wood EM, Mim R, Howe S, Ofidis D, Egleston BL, Harkins K, Largent EA, Roberts JS, Reiman EM, Denkinger M, Ashton NJ, Karlawish J, Bradbury AR, Langbaum JB. Evaluation of self-mediated alternatives for risk testing education and return of results (eSMARTER) study: A randomized study of methods for returning APOE and pTau-217 results. Alzheimers Dement (N Y). 2025 Nov 16;11(4):e70177. doi: 10.1002/trc2.70177. eCollection 2025 Oct-Dec.

  PMID: 41250770 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jessica Langbaum, PhD

  Banner Alzheimer's Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 14, 2024
• Study Start: October 10, 2024
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared within 12 months after study completion

Locations

US (2)