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

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06459583
• Lead Sponsor: Banner Health

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.

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-14
• Study Start: 2024-10-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 681

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety as measured by the PROMIS Anxiety scale	T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)	Anxiety scale
Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale	T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)	Knowledge of Genetic Disease scale
Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale	T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)	Disease-specific distress scale

Secondary Outcome Measures

Name	Time	Method
Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)	0-7 days, 6 weeks, 6 months	Depression scale
Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale	6 months	Psychological wellbeing scale
Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study	0-7 days, 6 weeks, 6 months	Perceived risk of Alzheimer's scale
Impact of disclosure as measured by the 16-item IGT-AD scale	0-7 days, 6 weeks, 6 months	Impact of genetic testing for Alzheimer's disease (IGT-AD) scale
Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument	6 months	Subjective cognitive concerns scale
Stigma as measured by the 6-item Stigma Impact Scale	0-7 days, 6 weeks, 6 months	Stigma scale

Trial Locations

Locations (2)

Accellacare Clinical Research Site 02; 🇺🇸 Mount Pleasant, South Carolina, United States

Accellacare Clinical Research Site 01; 🇺🇸 Bristol, Tennessee, United States