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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG058468 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth platform | Experimental | The eHealth platform consists of the self-directed web-portal (ADWebPortal) and chatbot (ADChatbot) to receive their Alzheimer's-related test results. Participants randomized to this arm can switch between the two or schedule a virtual appointment with a healthcare provider. |
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| Videoconference telehealth | Active Comparator | The videoconference telehealth platform consists of remote visit(s) with a healthcare provider to receive their Alzheimer's-related test results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth Platform | Other | The eHealth Platform consists of the ADWebPortal and ADChatbot for receiving Alzheimer's-related test results |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety as measured by the PROMIS Anxiety scale | Anxiety scale | T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure) |
| Knowledge of Genetic Disease as measured by an 8-item scale adapted from the Cancer Genetics Knowledge Scale and ClinSeq Knowledge Scale | Knowledge of Genetic Disease scale | T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure) |
| Disease-specific distress as measured by an 8-item scale adapted from the Impact of Events Scale | Disease-specific distress scale | T2 minus T1 change scores (6-weeks post disclosure minus 0-7 days post disclosure) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as measured by the Patient Health Questionnaire - 9 (PHQ-9) | Depression scale | 0-7 days, 6 weeks, 6 months |
| Psychological wellbeing as measured by a 14-item scale adapted from the Psychological Wellbeing Scale |
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Inclusion Criteria:
Exclusion Criteria:
Participant reports prior knowledge of APOE genotype.
Lack of psychological readiness to receive AD gene and biomarker information as indicated by:
Presence of current major psychiatric illness, e.g., psychosis, bipolar disorder, PTSD
Communication difficulties such as:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Langbaum, PhD | Banner Alzheimer's Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accellacare Clinical Research Site 02 | Mt. Pleasant | South Carolina | 29464 | United States | ||
| Accellacare Clinical Research Site 01 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250770 | Background | Erickson CM, Langlois CM, Wood EM, Mim R, Howe S, Ofidis D, Egleston BL, Harkins K, Largent EA, Roberts JS, Reiman EM, Denkinger M, Ashton NJ, Karlawish J, Bradbury AR, Langbaum JB. Evaluation of self-mediated alternatives for risk testing education and return of results (eSMARTER) study: A randomized study of methods for returning APOE and pTau-217 results. Alzheimers Dement (N Y). 2025 Nov 16;11(4):e70177. doi: 10.1002/trc2.70177. eCollection 2025 Oct-Dec. |
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Trial dataset and biological samples will be shared with qualified investigators
Data will be shared within 12 months after study completion
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Videoconference Telehealth Platform | Other | Participants will have a video telehealth visit with a healthcare provider to receive Alzheimer's-related test results |
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Psychological wellbeing scale
| 6 months |
| Perceived risk of Alzheimer's as measured by a scale adapted from the REVEAL Study | Perceived risk of Alzheimer's scale | 0-7 days, 6 weeks, 6 months |
| Impact of disclosure as measured by the 16-item IGT-AD scale | Impact of genetic testing for Alzheimer's disease (IGT-AD) scale | 0-7 days, 6 weeks, 6 months |
| Subjective cognitive concerns as measured by the 14-item Cognitive Function Instrument | Subjective cognitive concerns scale | 6 months |
| Stigma as measured by the 6-item Stigma Impact Scale | Stigma scale | 0-7 days, 6 weeks, 6 months |
| Bristol |
| Tennessee |
| 37620 |
| United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |