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

Banner Health

Status: Completed

Conditions: Alzheimer Disease

Treatments: Other: eHealth Platform; Other: Videoconference Telehealth Platform

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06459583

API-0001

R01AG058468 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 681 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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681 participants in 2 patient groups

eHealth platform

Experimental group

Description:

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.

Treatment:

Other: eHealth Platform

Videoconference telehealth

Active Comparator group

Description:

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

Treatment:

Other: Videoconference Telehealth Platform