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NCT04309500 · ClinicalTrials.gov registry record · NA
SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT04309500 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 20 participants.
The verdict
NCT04309500, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Personalized DAT Risk Disclosure Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2022-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04309500
The ClinicalTrials.gov registry entry for NCT04309500 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Personalized DAT Risk Disclosure Protocol is the first listed.
NCT04309500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04309500 about?
NCT04309500 is a clinical study titled "SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting". 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 ...
What is the current status of trial NCT04309500?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2021-05-20. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT04309500?
The interventions under investigation include: Personalized DAT Risk Disclosure Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT04309500?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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