Clinical trial NCT06459583: Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Official title: Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: APOE
Lead sponsor: Banner Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Pennsylvania
First posted: 2024-06-14
Enrollment: 681
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Anxiety as measured by the PROMIS Anxiety scale
timeFrame: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)
measure: Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale
timeFrame: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)
measure: Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale
timeFrame: T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure)
Secondary outcomes:
measure: Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 0-7 days, 6 weeks, 6 months
measure: Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale
timeFrame: 6 months
measure: Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study
timeFrame: 0-7 days, 6 weeks, 6 months
measure: Impact of disclosure as measured by the 16-item IGT-AD scale
timeFrame: 0-7 days, 6 weeks, 6 months
measure: Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument
timeFrame: 6 months
measure: Stigma as measured by the 6-item Stigma Impact Scale
timeFrame: 0-7 days, 6 weeks, 6 months
Other outcomes:
Locations:
city: Mount Pleasant
country: United States
facility: Accellacare Clinical Research Site 02
state: South Carolina
city: Bristol
country: United States
facility: Accellacare Clinical Research Site 01
state: Tennessee
Study officials:
affiliation: Banner Alzheimer's Institute
name: Jessica Langbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References: