NCT06459583

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 681 (actual)
• Sponsor: Banner Health · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	eHealth Platform	The eHealth Platform consists of the ADWebPortal and ADChatbot for receiving Alzheimer's-related test results
OTHER	Videoconference Telehealth Platform	Participants will have a video telehealth visit with a healthcare provider to receive Alzheimer's-related test results

Timeline

• Start date: 2024-10-10
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2024-06-14
• Last updated: 2026-01-14

Locations

2 sites across 1 country: United States