CompletedNot Applicable

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

United States20 participantsStarted 2021-05-20

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) * Sever…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comprehension/Recall of Results - Personal Information Score - PARTICIPANT

Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure

Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS

Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure

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

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

Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS

Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure

Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS

Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure

Trial details

NCT IDNCT04309500

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31

Results submitted2023-01-20

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