Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459583
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-14
First Post:
2024-05-23
Brief Title:
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Sponsor:
Banner Health
Organization:
Banner Health
Study Overview
Official Title:
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eSMARTER
Brief Summary:
This randomized non-inferiority study will evaluate self-directed scalable electronic health platform eHealth methods for communicating Alzheimers 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 Alzheimers 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 Alzheimers 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 eg blood draw will be completed remotely using mobile health services
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 eg blood draw will be completed remotely using mobile health services
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG058468 | NIH | None | httpsreporternihgovquickSearchR01AG058468 |