Clinical trial NCT04309500: SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
Official title: Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Healthy Aging
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Beck Anxiety Inventory (BAI) - PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
measure: The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
timeFrame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Secondary outcomes:
Other outcomes:
measure: Comprehension of Results - Qualitative Impressions
timeFrame: Administered immediately after risk disclosure; 1 week later, and 6 weeks later
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School, Department of Psychiatry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Annalise M Rahman-Filipiak, PhD
role: PRINCIPAL_INVESTIGATOR
References: