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

Alzheimer Disease Clinical Trial

— eSMARTER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459583
• Other study ID #: API-0001
• Secondary ID: R01AG058468
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Banner Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 University of Pennsylvania healthcare provider or by eHealth platform. A permuted block design will be used for randomization, and we will stratify by sex and 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. Participants will visit relevant medical facilities as required for completion of study related procedures necessitating physical attendance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: November 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Banner Health	National Institute on Aging (NIA), University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety as measured by the PROMIS Anxiety scale		T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)
Primary	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)
Primary	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)
Secondary	Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)		0-7 days, 6 weeks, 6 months
Secondary	Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale		6 months
Secondary	Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study		0-7 days, 6 weeks, 6 months
Secondary	Impact of disclosure as measured by the 16-item IGT-AD scale		0-7 days, 6 weeks, 6 months
Secondary	Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument		6 months
Secondary	Stigma as measured by the 6-item Stigma Impact Scale		0-7 days, 6 weeks, 6 months