eSMARTER
Evaluation of Self-Mediated Alternatives for Risk Testing Education and Return of Results (eSMARTER)
Trial Overview
eSMARTER is a decentralized, randomized trial to evaluate self-directed scalable eHealth methods for communicating Alzheimer’s disease gene and biomarker risk information and test results, as well as characterize the clinical impacts of learning this information.
The availability of amyloid-modifying therapies is dramatically increasing the need for disclosure of this type of information. In addition, the 21st Century Cares Act requires the immediate return of most medical test results, including Alzheimer’s gene and biomarker results. Given the existing shortage of genetic counselors and dementia specialists, there is great need for the development and deployment of scalable self-directed methods to responsibly communicate gene and biomarker test information and results.
eSMARTER will enroll approximately 600 adults aged 60-80 from the GeneMatch program. Study participants are randomized to receive their Alzheimer’s gene and biomarker risk information and test results either via person-mediated telehealth videoconference visit with a healthcare provider or independently by eHealth self-directed digital platform. Participants complete online assessments before and after learning their test results to evaluate the tolerability and effectiveness of using e-health technologies for communication of Alzheimer’s risk information and related test results without direct provider interface. We gratefully acknowledge the participants and their family members.
Our Partners
Design and implementation of the eSMARTER study was led collaboratively by Banner Alzheimer’s Institute and the Alzheimer’s Clinical Trial Consortium (ACTC) in partnership with University of Pennsylvania and University of Michigan, and numerous academic advisors.
The study is supported by a grant from the National Institute on Aging (5R01AG058468).