STIM+: PET Biomarker Education & Disclosure

Primary outcomes

1. Participant Interest in PET Biomarker Disclosure

   Time frame: Immediately Following Pre-Disclosure Education Session (within one month of enrollment)

   Percent of participants surveyed who were interested in receiving their PET biomarker feedback following education, prior to disclosure

2. Percent of Individuals Demonstrating Disclosure Decision-making Capacity

   Time frame: Immediately Following Pre-Disclosure Education Session (within one month of enrollment)

   This interactive interview involves an assessment of understanding, appreciation, rationale, and communication of a decision regarding participating or not participating in PET biomarker disclosure. During an education session in which information about PET disclosure is reviewed, participants are asked questions to determine how well they comprehend and appreciated risks and benefits of engaging in PET biomarker disclosure. They are provided with prompts/clarification as needed. Examiners subjectively score each response as correct or incorrect and utilize this information to determine whether participants are demonstrate decisional capacity for PET biomarker disclosure. Results are pass (disclosure decisional capacity intact) or fail (disclosure decisional capacity not intact). Therefore, we will measure the percent of individuals who are able to pass this measure.

3. Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score

   Time frame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)

   This 10-item subscale asks respondents to rate the extent to which they are experiencing positive (e.g., excited, inspired) emotions on a Likert-style scale ranging from '1 = Very Slightly or Not at All' to '5=Extremely.' Scores range from 10-50, with higher scores indicating higher positive emotions.

4. Effect of Disclosure (Time) and Biomarker Status on Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score

   Time frame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

   This 10-item subscale asks respondents to rate the extent to which they are experiencing positive negative (e.g., distressed, ashamed) emotions on a Likert-style scale ranging from '1 = Very Slightly or Not at All' to '5=Extremely.' The scores range from 10-50, with higher scores indicating higher negative emotions.

5. Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score

   Time frame: Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)

   Measures negative reactions to AD-related personal neuroimaging results received as part of disclosure (0-55; higher scores indicate higher distress) starting from immediately following disclosure to six weeks post-disclosure.

6. Effect of Biomarker Status on Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score

   Time frame: Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure (within 6.5 months of baseline), and 6-weeks post-disclosure (within 8 months of baseline)

   Measures change in positive reactions to AD-related personal neuroimaging results received as part of disclosure (0-20; higher scores indicate higher positive emotions) starting from immediately following disclosure to six weeks post-disclosure.

7. Effect of Disclosure (Time) and Biomarker Status on Stigma Scale for Chronic Illness (SSCI-8) Total Score

   Time frame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

   The Stigma Scale for Chronic Illness (SSCI-8) measures perceived and experienced stigma based on a chronic illness (in this case, cognitive disorder). The SSCI-8 demonstrates strong reliability for the measurement of both internalized (perceived) and enacted (experienced) stigma perceived by individuals with chronic neurological conditions. Respondents complete 8 items about experiences of stigma, rated on a Likert-style scale from 1 = 'Never' to 5 = 'Always'. Items are summed to a total score (min=8, max=40) with higher scores suggesting more stigma.

8. Effect of Disclosure (Time) and Biomarker Status on Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score

   Time frame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

   The Self-Efficacy for Managing Chronic Disease (SECD) scale is a 6-item scale that measures perceived ability to self-manage the physical, emotional, and cognitive symptoms associated with their chronic disease. Items are listed on a 10-point scale ranging from 1 = 'Not at all confident' to 10 = 'Totally confident'. Item scores are summed and averaged. Lower scores suggest lower confidence in managing symptoms. Higher scores suggest higher confidence in managing symptoms. There are no clinical cut-offs for this measure.

9. Effect of Disclosure (Time) and Biomarker Status on Future Time Perspectives Scale (FTP) Average Score

   Time frame: Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure

   The Future Time Perspective (FTP) scale is a 10-item scale that measures the extent to which respondents feel that they have potential for productive and functional years ahead of them. Statements regarding positive and negative future time perspective are rated on a 7-point Likert-style scale, ranging from 1= 'Very untrue' to 7='Very true.' 3 items are reverse scored, then all items are summed and averaged. Minimum average score is 1, maximum average score is 7. Higher scores suggest greater time perspective.

10. Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure

    Time frame: Immediately following disclosure (within 6 months of baseline)

    This tool, created for the purpose of this study, measures participant's ability to understand their biomarker results and their meaning. Scores on the nine items are converted into a percent correct score, with higher scores indicating better comprehension and memory of results.

11. Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 1-Week Post-Disclosure

    Time frame: 1-week post-disclosure (within 6.5 months of baseline)

    This tool, created for the purpose of this study, measures participant's ability to understand their biomarker results and their meaning. Scores on the nine items are converted into a percent correct score, with higher scores indicating better comprehension and memory of results.

12. Effect of Diagnosis on Participant Comprehension/Recall of Results Percent Correct Score: 6-Week Post-Disclosure

    Time frame: 6 weeks post-disclosure (within 8 months of baseline)

    This tool, created for the purpose of this study, measures participant's ability to understand their biomarker results and their meaning. Scores on the nine items are converted into a percent correct score, with higher scores indicating better comprehension and memory of results.

13. Preparedness for Caregiving Scale (PCS)

    Time frame: Measured at baseline, immediately post-disclosure (within 6 months of baseline), and at 1- (within 6.5 months of baseline) and 6-weeks post-disclosure (within 8 months of baseline)

    This 8-item measure assesses the degree to which care partners of persons with cognitive impairment (e.g., MCI, DAT) perceive they are prepared for and able to manage various domains of caregiving such as providing physical care and emotional support, setting up in-home support services, and coping with stress due to caregiving. Items use a 5-point likert scale ranging from 0 = 'Not at all prepared' to 4 'Very well prepared'. An average score is generated (min=0, max=4) with higher scores indicating greater preparedness.

14. Revised Scale for Caregiving Self-Efficacy

    Time frame: Measured at baseline, immediately post-disclosure (within 6 months of baseline), and at 1- (within 6.5 months of baseline) and 6-weeks post-disclosure (within 8 months of baseline)

    The Revised Scale for Caregiving Self-Efficacy is a 15-item scale consisting of 3 sub-scales, each containing 5-items, designed to measure perceived ability to manage aspects related to caregiving among caregivers of persons with dementia. Only one subscale was administered in this study: this 5-item subscale is used to measure the co-participant's perceived ability to manage the emotional stresses associated with caregiving. This measure will be administered to study partners only. Items are averaged (min=0, max=100) with higher scores indicating greater perceived confidence to manage the emotional stressed of caregiving.