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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03AG063222-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this study is to test efficacy and safety of person-centered, culturally-informed protocols for disclosure of different combinations of Alzheimer's dementia risk factors. Building on the results from a federally-funded assessment of preferences and needs of racially diverse participants and their respective friends/family members, in regard to Dementia - Alzheimer's Type (DAT), we have produced protocols for communication of DAT risk, with attention to specific adaptations in style or content based on individual factors and preferences. These protocols allow for communication of risk based on clinical history and diagnosis, structural neuroimaging, apolipoprotein-E status, and amyloid and tau burden on positron emission tomography. In particular, protocols specify (a) effective methods of communicating risk conferred by each data source, (b) information designed for patients versus informants, (c) psychoeducation needs, and (d) resource/support needs. We will recruit a randomly-selected subset of 10 dyads (including 5 participants who are Non-Hispanic African-American, 5 participants who are Non-Hispanic White) from the Stage I sample to whom we will develop and implement personalized DAT risk disclosure protocols. We will provide preliminary information on the effectiveness of these protocols in terms of patient/co-participant comprehension and recall of feedback provided, and initial changes in mood or behavior immediately following and shortly after risk disclosure sessions.
Currently, a divide exists between Dementia - Alzheimer's Type (DAT) risk information that is shared in clinical settings versus genetic and biomarker-based risk information gathered and, less frequently, disseminated in research settings. Clinical feedback continues to discuss DAT risk in terms of personal/family history, neuropsychological or neurological testing, and standard neuroimaging reports. Research advances in genotyping, quantitative neuroimaging, and amyloid and tau positron emission tomography (PET) have improved our risk prediction and disease staging; however, the literature on how to share these important findings is sparse. Effective risk disclosure protocols are fundamentally dependent on the needs of recipients. However, we do not know how patients, or those tasked with current or future caregiving, decide what sources or types of risk information they want disclosed, nor their reasons for preferring certain types of information over others. Given the differences between static (e.g., family history, genotyping) and dynamic, potentially modifiable risk factors (e.g., amyloid burden), as well as varying familiarity with research-based biomarkers, it is especially important to understand how much information patients hope to receive and what they hope to do with it. This knowledge gap is particularly pertinent in minority and low-income populations given systemic challenges and cultural beliefs that may affect their psychological, physical, and financial ability to adapt to a high risk profile. Thus, understanding risk disclosure needs and preferences is a critical step in developing culturally-informed feedback protocols.
Aim 1 (accomplished during the Stage I observational Needs Assessment - HUM00160276) was to investigate the preferences and needs of racially diverse participants, and their respective informants, in regards to receiving feedback about their risk for DAT.
Aim 2 is to develop person-centered, culturally-informed protocols for disclosure of different combinations of Alzheimer's dementia risk factors. Building on the results of Aim 1, we have produced protocols for communication of DAT risk, with attention to specific adaptations in style or content based on individual factors and preferences. In particular, protocols specify (a) effective methods of communicating risk conferred by each data source, (b) information designed for patients versus informants, (c) psychoeducation needs, and (d) resource/support needs. We will recruit a randomly-selected subset of 10 dyads (including 5 participants who are Non-Hispanic African-American, 5 participants who are Non-Hispanic White) from the Stage I sample to whom we will develop and implement personalized DAT risk disclosure protocols. We will provide preliminary information on the effectiveness of these protocols in terms of patient/co-participant comprehension and recall of feedback provided, and initial changes in mood or behavior immediately following and shortly after risk disclosure sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloid Positive (Tau Positive or Negative) Participants | Experimental | Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. |
|
| Amyloid Negative (Tau Positive or Negative) Participants | Experimental | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. |
|
| Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Experimental | Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. |
|
| Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Experimental | Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized DAT Risk Disclosure Protocol | Behavioral | Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehension/Recall of Results - Personal Information Score - PARTICIPANT | Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS | Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS | Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS | Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comprehension of Results - Qualitative Impressions | Participants and co-participants were asked to explain, in their own words and without cuing, their impressions of the messages they received about the participant's clinical history, structural neuroimaging, genetic profile, and amyloid and tau biomarkers, as well as the risk for DAT conferred by those markers. Responses were transcribed and coded to determine core themes and understanding of risk messages. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annalise M Rahman-Filipiak, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Medical School, Department of Psychiatry | Ann Arbor | Michigan | 48105 | United States |
No individual participant data will be made available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amyloid Positive (Tau Positive or Negative) Participants | Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| FG001 | Amyloid Negative (Tau Positive or Negative) Participants | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| FG002 | Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| FG003 | Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amyloid Positive (Tau Positive or Negative) Participants | Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comprehension/Recall of Results - Personal Information Score - PARTICIPANT | Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct. | 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | percentage correct | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
six weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amyloid Positive (Tau Positive or Negative) Participants | Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annalise M. Rahman-Filipiak | University of Michigan | 734-763-9259 | rahmanam@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 | Sep 29, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form - Co-Participants | Jan 26, 2022 | Sep 9, 2022 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form - Participants | Jan 26, 2022 | Nov 28, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Stage II will involve a clinical trial, with the risk disclosure feedback serving as the behavioral intervention. The study will use a single-group design with no control group. All 10 participant-co-participant dyads (5 Non-Hispanic African-American, 5 Non-Hispanic White) will receive feedback about the participant's DAT risk. Outcomes will be measured immediately following feedback and at 1- and 6-weeks following risk disclosure.
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|
| Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS | A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms).Participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS | A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms). Co-participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Beck Anxiety Inventory (BAI) - PARTICIPANTS | A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS | A 21-item measure of the perceived severity ('not at all' to 'severely') at which the co-participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. Possible scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Co-participants completed this to assess their reactions to the participant receiving risk feedback. Scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results. | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
| Administered immediately after risk disclosure; 1 week later, and 6 weeks later |
| BG001 | Amyloid Negative (Tau Positive or Negative) Participants | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| BG002 | Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| BG003 | Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Continuous Years of Education | Mean | Standard Deviation | years |
|
| Baseline Beck Anxiety Inventory (BAI) | A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant is experiencing anxiety symptoms over the past week, validated for use with older adults. The range of the scores is 0-63, with higher scores meaning greater anxiety. | Mean | Standard Deviation | score on a scale |
|
| Baseline Geriatric Depression Scale (GDS) | A 15-item assessment of depressive symptoms that has been adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms). It asks the participant to rate the presence of mood symptoms over the past two weeks. Scores on the adapted assessment range from 0-15, with higher scores indicating more depressive symptoms. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Amyloid Negative (Tau Positive or Negative) Participants | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. |
|
|
| Primary | Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS | Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct. | 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week evaluation. | Posted | Mean | Standard Deviation | percentage correct | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
|
|
| Primary | Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS | Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct. | 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | percentage correct | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
|
|
| Primary | Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS | Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct. | 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week evaluation. | Posted | Mean | Standard Deviation | percentage correct | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
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| Primary | Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS | A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms).Participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms | GDS was erroneously not collected for 1 participant in each arm at the immediate and 1-week time point. 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
|
|
| Primary | Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS | A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms). Co-participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms | GDS was erroneously not collected for 1 study partner in each arm at the immediate and 1-week time point. 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up, as it fell outside of the study funding period. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
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| Primary | Beck Anxiety Inventory (BAI) - PARTICIPANTS | A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety. | BAI was erroneously not collected for 1 participant in each arm at the immediate and 1-week time point. 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
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| Primary | Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS | A 21-item measure of the perceived severity ('not at all' to 'severely') at which the co-participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety. | BAI was erroneously not collected for 1 study partner in each arm at the immediate and 1-week time point. 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up, as it fell outside of the study funding period. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
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| Primary | The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. Possible scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions. | 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
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| Primary | The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Co-participants completed this to assess their reactions to the participant receiving risk feedback. Scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions. | One study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up as it fell outside of the study funding period. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
|
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| Primary | The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results. | 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
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| Primary | The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS | The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results. | One participant in the "Co-Participant of Amyloid Positive" arm did not complete the 6-week follow-up as it fell outside of the study funding period. | Posted | Mean | Standard Deviation | score on a scale | Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure |
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| Other Pre-specified | Comprehension of Results - Qualitative Impressions | Participants and co-participants were asked to explain, in their own words and without cuing, their impressions of the messages they received about the participant's clinical history, structural neuroimaging, genetic profile, and amyloid and tau biomarkers, as well as the risk for DAT conferred by those markers. Responses were transcribed and coded to determine core themes and understanding of risk messages. | Not Posted | Administered immediately after risk disclosure; 1 week later, and 6 weeks later | Participants |
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Amyloid Negative (Tau Positive or Negative) Participants | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed. | 0 | 5 | 0 | 5 | 0 | 5 |
Not provided
Not provided
Not provided
| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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| 1 week after disclosure |
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| 6 weeks after disclosure |
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