Back to resultsSTIM+: PET Biomarker Education & Disclosure (STIM+)
Primary Purpose
Mild Cognitive Impairment, Dementia; Alzheimer's Type (Etiology)
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET Biomarker Disclosure
Sponsored by
About this trial
This is an interventional health services research trial for Mild Cognitive Impairment
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the Stimulation to Improve Memory Study (NCT03875326).
- Completed PET scan with amyloid and/or tau tracer success.
- Demonstrates decision-making capacity to engage in PET disclosure, or has a care partner in attendance that demonstrates decision-making capacity for the participant to engage in disclosure
- If diagnosed with DAT: must have a cognitively intact study partner (i.e., their care partner)
- If diagnosed with MCI: strongly recommended to have a cognitively intact study partner (i.e., their care partner)
Exclusion Criteria:
- Active diagnosis of moderate depression or anxiety without treatment
- Newly diagnosed neurologic disease (since completion of Stimulation to Improve Memory Study activities)
Sites / Locations
- University of Michigan Medical School, Department of Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Disclosure
Arm Description
Participants who demonstrated decisional capacity for and interest in disclosure (or whose care partner is able to do so) will receive the participant's personalized PET amyloid and tau biomarker status, as well as information about the meaning and clinical utility of this information and recommendations for next steps (e.g., discussing findings with his/her provider).
Outcomes
Primary Outcome Measures
Interest in PET Biomarker Disclosure
Percent of individuals surveyed who were interested in receiving their PET biomarker feedback prior to disclosure
Percent of individuals demonstrating disclosure decision-making capacity
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.
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score
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.
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score
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.
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score
Measures change in 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.
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score
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.
Change in Stigma Scale for Chronic Illness (SSCI-8) Total Score
The SSCI-8 demonstrates strong reliability for the measurement of both internalized and enacted 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.'
Change in Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score
The SECD 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'.
Change in Future Time Perspectives Scale (FTP) Average Score
This 10-item scale 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.'
Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure
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.
Change in Participant Comprehension/Recall of Results Percent Correct Score
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04818255
First Posted
March 3, 2021
Last Updated
January 11, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04818255
Brief Title
STIM+: PET Biomarker Education & Disclosure
Acronym
STIM+
Official Title
Stimulation to Improve Memory: PET Education & Disclosure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
When dementia is caused by AD, we refer to it as dementia of the Alzheimer's Type (DAT). The greatest risk factor for Alzheimer's Disease (AD) and DAT is advancing age, but DAT is not a normal part of aging. Studies have shown that changes in the brain happen before full symptoms of DAT develop. These changes include a buildup of two proteins within the brain, called amyloid and tau. The two goals of this study are
(1) to determine whether patients with mild cognitive impairment or dementia-Alzheimer's type (DAT) are able to demonstrate decisional capacity to engage in PET amyloid and tau disclosure after receiving education; and (2) to assess how patients and care partners react to PET amyloid and tau biomarker disclosure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Dementia; Alzheimer's Type (Etiology)
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants and care partners who demonstrate intact decisional capacity to engage in PET biomarker disclosure, and who wish to receive the participant's PET results will be provided with education, results, and recommendations for next steps and supportive resources (the intervention). After this intervention, participants will complete follow-up evaluations of mood and anxiety within one week and at six weeks post disclosure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Disclosure
Arm Type
Experimental
Arm Description
Participants who demonstrated decisional capacity for and interest in disclosure (or whose care partner is able to do so) will receive the participant's personalized PET amyloid and tau biomarker status, as well as information about the meaning and clinical utility of this information and recommendations for next steps (e.g., discussing findings with his/her provider).
Intervention Type
Behavioral
Intervention Name(s)
PET Biomarker Disclosure
Intervention Description
Participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging conducted as part of an affiliated research study (no additional imaging is required for this project). Participants meet with a licensed clinical neuropsychologist to discuss their biomarker status, the meaning of this information, and potential next steps to consider based of their status. Participants receive written summaries of this information, as well as resources as deemed necessary or as requested.
Primary Outcome Measure Information:
Title
Interest in PET Biomarker Disclosure
Description
Percent of individuals surveyed who were interested in receiving their PET biomarker feedback prior to disclosure
Time Frame
At Baseline (at consent session, lasting up to 120 minutes)
Title
Percent of individuals demonstrating disclosure decision-making capacity
Description
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.
Time Frame
At Baseline (at consent session, lasting up to 120 minutes)
Title
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Positive Subscale Score
Description
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.
Time Frame
Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Title
Change in Positive and Negative Affect Scale - Short Form (PANAS-SF) Negative Subscale Score
Description
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.
Time Frame
Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Title
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Distress Score
Description
Measures change in 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.
Time Frame
Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
Title
Change in Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Positive Emotions Score
Description
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.
Time Frame
Change from Immediately following disclosure (within 6 months of baseline) to 1-week post-disclosure and 6-weeks post-disclosure
Title
Change in Stigma Scale for Chronic Illness (SSCI-8) Total Score
Description
The SSCI-8 demonstrates strong reliability for the measurement of both internalized and enacted 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.'
Time Frame
Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Title
Change in Self-Efficacy for Managing Chronic Disease Scale (SECD) Total Score
Description
The SECD 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'.
Time Frame
Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Title
Change in Future Time Perspectives Scale (FTP) Average Score
Description
This 10-item scale 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.'
Time Frame
Change from Baseline to Immediately following disclosure (within 6 months of baseline), 1-week post-disclosure, and 6-weeks post-disclosure
Title
Participant Comprehension/Recall of Results Percent Correct Score: Immediately Following Disclosure
Description
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.
Time Frame
Immediately following disclosure, lasting up to 120 minutes.
Title
Change in Participant Comprehension/Recall of Results Percent Correct Score
Description
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.
Time Frame
Change from immediately following disclosure, 1-week following disclosure, and 6-weeks following disclosure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled in the Stimulation to Improve Memory Study (NCT03875326).
Completed PET scan with amyloid and/or tau tracer success.
Demonstrates decision-making capacity to engage in PET disclosure, or has a care partner in attendance that demonstrates decision-making capacity for the participant to engage in disclosure
If diagnosed with DAT: must have a cognitively intact study partner (i.e., their care partner)
If diagnosed with MCI: strongly recommended to have a cognitively intact study partner (i.e., their care partner)
Exclusion Criteria:
Active diagnosis of moderate depression or anxiety without treatment
Newly diagnosed neurologic disease (since completion of Stimulation to Improve Memory Study activities)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Hampstead, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Medical School, Department of Psychiatry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with researchers outside of this study.
Learn more about this trial
STIM+: PET Biomarker Education & Disclosure
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