SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting

Mild Cognitive Impairment Clinical Trial

— SHARE(D)  

Official title:

Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309500
• Other study ID #: HUM00178869
• Secondary ID: 1R03AG063222-01
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age 65+ years
• Non-Hispanic Black or Non-Hispanic White race/ethnicity
• Previously participated in Stage I (observational needs assessment)
• Have completed an initial evaluation as part of the University of Michigan Memory and Aging Project (UM-MAP), Stimulation to Improve Memory (STIM) study, or the DAPPER study within the last 12 months.
• Diagnosed with normal cognition or mild cognitive impairment (MCI; single- or -multiple domain, amnestic or non-amnestic forms)
• Able to identify a co-participant who is currently the participant's caregiver, or would serve in this role in the future if needed, and well-known to the participant (known for =5 years and have at least weekly phone or in-person contact)
• Able to identify a co-participant who is 18+ years old.
• Able to identify a co-participant who is cognitively healthy

Exclusion Criteria:

• Current or historical neurologic disorder (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
• Current or historical significant neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness > 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention).
• Motor symptoms indicative of a neurodegenerative etiology other than Alzheimer's disease
• Severe mental illness (i.e., bipolar disorder, thought disorder, psychosis)
• Severe substance use disorder

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Aging
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Medical School, Department of Psychiatry	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Administered immediately after risk disclosure; 1 week later, and 6 weeks later
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	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.	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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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	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	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.	Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure