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

NCT ID: NCT06459583

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 681 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2025-11-07

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.

Detailed Description

This is a randomized trial to evaluate self-directed scalable eHealth methods for communicating Alzheimer's gene and biomarker results, as well as characterize the clinical impacts of learning this information on the participant. All participants in the study will be randomized to receive their Alzheimer's gene and biomarker results either via person-mediated telehealth videoconference visit with a healthcare provider or by eHealth platform. A permuted block design will be used for randomization, and we will stratify by sex and apolipoprotein E (APOE) genotype.

Participants randomized to the eHealth arm will be offered either the ADWebPortal or ADChatbot but can switch between platforms or schedule a virtual appointment to speak with a healthcare provider at any point. Use of the pre-disclosure education platforms will be tracked. A HIPAA compliant telehealth application will be used for the person-mediated telehealth videoconference visits and sessions will be recorded.

Potential participants will be identified from the GeneMatch program. Study management and participation will be decentralized. Confirmation of eligibility and consent of potential participants will be completed remotely by a decentralized study team. Procedures requiring physical attendance (e.g., blood draw) will be completed remotely using mobile health services.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

eHealth platform

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.

Group Type: EXPERIMENTAL

eHealth Platform

Intervention Type: OTHER

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

Videoconference telehealth

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

Group Type: ACTIVE_COMPARATOR

Videoconference Telehealth Platform

Intervention Type: OTHER

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

Interventions

eHealth Platform

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

Intervention Type: OTHER

Videoconference Telehealth Platform

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Participant reports prior knowledge of APOE genotype.
• Lack of psychological readiness to receive AD gene and biomarker information as indicated by:

1. obtaining a score of 10 or greater on the Patient Health Questionnaire - 9 (PHQ-9) AND/OR

2. 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:

1. Uncorrected or uncompensated hearing and/or vision impairment.

2. Uncorrected or uncompensated speech defects.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Banner Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Langbaum, PhD

Role: PRINCIPAL_INVESTIGATOR

Banner Alzheimer's Institute

Locations

Accellacare Clinical Research Site 02

Mt. Pleasant, South Carolina, United States

Accellacare Clinical Research Site 01

Bristol, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 41250770 (View on PubMed)

Other Identifiers

R01AG058468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

API-0001

Identifier Type: -

Identifier Source: org_study_id