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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04309500
Recruitment Status : Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Annalise Rahman-Filipiak, University of Michigan

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, 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, satisfaction with the content and format of feedback, and initial changes in mood or behavior immediately following and shortly after risk disclosure sessions.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Healthy Aging Behavioral: Personalized DAT Risk Disclosure Protocol Not Applicable

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, satisfaction with the content and format of feedback, and initial changes in mood or behavior immediately following and shortly after risk disclosure sessions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: African-American Participant-Co-Participant Dyads
5 Non-Hispanic African-American participants and their respective caregivers will receive semi-structured personalized feedback regarding their risk for Dementia-Alzheimer's type (DAT).
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.

Experimental: White Participant-Co-Participant Dyads
5 Non-Hispanic White participants and their respective caregivers will receive semi-structured personalized feedback regarding their risk for Dementia-Alzheimer's type (DAT)
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.




Primary Outcome Measures :
  1. Comprehension/Recall of Results - Personal Information Score (Immediate) [ Time Frame: Administered immediately after risk disclosure ]
    This questionnaire asks participants/co-participants 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.

  2. Comprehension/Recall of Results - Personal Information Score (1-week Follow-Up) [ Time Frame: Administered at 1 week post risk disclosure ]
    This questionnaire asks participants/co-participants 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.

  3. Comprehension/Recall of Results - Personal Information Score (6-week Follow-Up) [ Time Frame: Administered at 6 weeks post risk disclosure ]
    This questionnaire asks participants/co-participants 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.

  4. Comprehension/Recall of Results - Meaning of Risk Information Score (Immediate) [ Time Frame: Administered immediately after risk disclosure ]
    This questionnaire asks participants/co-participants 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 is related to increased, decreased, or unclear risk for DAT).

  5. Comprehension/Recall of Results - Meaning of Risk Information Score (1-week Follow-Up) [ Time Frame: Administered at 1 week post risk disclosure ]
    This questionnaire asks participants/co-participants 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 is related to increased, decreased, or unclear risk for DAT).

  6. Comprehension/Recall of Results - Meaning of Risk Information Score (6-week Follow-Up) [ Time Frame: Administered at 6 weeks post risk disclosure ]
    This questionnaire asks participants/co-participants 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 is related to increased, decreased, or unclear risk for DAT).

  7. Geriatric Depression Scale - Short Form (GDS-15; Immediate) [ Time Frame: Administered immediately after risk disclosure ]
    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/co-participant to rate the presence of mood symptoms over the past two weeks.

  8. Geriatric Depression Scale - Short Form (GDS-15; 1-week Follow-Up) [ Time Frame: Administered at 1 week post risk disclosure ]
    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/co-participant to rate the presence of mood symptoms over the past two weeks.

  9. Geriatric Depression Scale - Short Form (GDS-15; 6-week Follow-Up) [ Time Frame: Administered at 6 weeks post risk disclosure ]
    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/co-participant to rate the presence of mood symptoms over the past two weeks.

  10. Beck Anxiety Inventory (BAI; Immediate) [ Time Frame: Administered immediately after risk disclosure ]
    A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant/co-participant is experiencing anxiety symptoms over the past week, validated for use with older adults.

  11. Beck Anxiety Inventory (BAI; 1-week follow-up) [ Time Frame: Administered at 1 week post risk disclosure ]
    A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant/co-participant is experiencing anxiety symptoms over the past week, validated for use with older adults.

  12. Beck Anxiety Inventory (BAI; 6-week Follow-Up) [ Time Frame: Administered at 6 weeks post risk disclosure ]
    A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant/co-participant is experiencing anxiety symptoms over the past week, validated for use with older adults.

  13. The Impact of Genetic Testing for AD (IGT-AD; Immediate) [ Time Frame: Administered immediately after risk disclosure ]
    The Impact of Genetic Testing for AD (IGT-AD) is a 16-item self-report measure that assesses two positive and negative emotional responses to genetic AD risk disclosure. We will adapt this scale to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Both participants and co-participants will complete this to assess their reactions to the participant receiving risk feedback.

  14. The Impact of Genetic Testing for AD (IGT-AD; 1-week Follow-Up) [ Time Frame: Administered at 1 week after risk disclosure ]
    The Impact of Genetic Testing for AD (IGT-AD) is a 16-item self-report measure that assesses two positive and negative emotional responses to genetic AD risk disclosure. We will adapt this scale to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Both participants and co-participants will complete this to assess their reactions to the participant receiving risk feedback.

  15. The Impact of Genetic Testing for AD (IGT-AD; 6-week Follow-Up) [ Time Frame: Administered at 6 weeks after risk disclosure ]
    The Impact of Genetic Testing for AD (IGT-AD) is a 16-item self-report measure that assesses two positive and negative emotional responses to genetic AD risk disclosure. We will adapt this scale to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Both participants and co-participants will complete this to assess their reactions to the participant receiving risk feedback.

  16. Satisfaction Questionnaire [ Time Frame: Administered immediately after risk disclosure ]
    Participants and Co-Participants will be asked to rate their satisfaction with different elements of the feedback process, as well as feedback overall, using Likert-style responses (1 = Not at All Satisfied; 5 = Very Satisfied).


Secondary Outcome Measures :
  1. Comprehension of Results - Qualitative Impressions [ Time Frame: Administered immediately after risk disclosure ]
    Participants and co-participants will be 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 will be transcribed and coded to determine core themes and understanding of risk messages.

  2. Recall of Results - Qualitative Impressions (1-week Follow-Up) [ Time Frame: Administered at 1 week post risk disclosure ]
    Participants and co-participants will be 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 will be transcribed and coded to determine core themes and understanding of risk messages.

  3. Recall of Results - Qualitative Impressions (6-week Follow-Up) [ Time Frame: Administered at 6 weeks post risk disclosure ]
    Participants and co-participants will be 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 will be transcribed and coded to determine core themes and understanding of risk messages.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  • Substance use disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309500


Contacts
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Contact: Annalise M Rahman-Filipiak, PhD 7349363180 rahmanam@umich.edu
Contact: Shima Sadaghiyani, BS 7347647402 ssadag@umich.edu

Locations
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United States, Michigan
University of Michigan Medical School, Department of Psychiatry
Ann Arbor, Michigan, United States, 48105
Contact: Annalise M Rahman-Filipiak, PhD    734-936-3180    rahmanam@umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute on Aging (NIA)
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Responsible Party: Annalise Rahman-Filipiak, Clinical Lecturer, University of Michigan
ClinicalTrials.gov Identifier: NCT04309500    
Other Study ID Numbers: HUM00178869
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be made available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders