Behavioral Change Following Culturally Informed Biomarker Disclosure in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Post-disclosure health behavior change as measured by the health behavior subscale score
研究概览
简要总结
The proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
- •Available PET Aβ and tau imaging
排除标准
- •Significant neurologic diagnosis (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
- •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 abnormalities indicative of a non-AD etiology
- •Severe mental illness (e.g., bipolar disorder, psychosis), moderate-severe mood or anxiety disorder, active substance use disorder (o reduce the likelihood of severe psychological distress, participants must screen negative for moderate-severe depressive or anxiety symptoms at study enrollment.)
- •Inability to provide independent informed consent.
研究组 & 干预措施
Biomarker and Diagnostic Disclosure
Participants receive information about their cognitive test results and research diagnosis. In addition, participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging. PET is a type of imaging biomarker (Aß-PET and tau PET) for clinical diagnosis of Alzheimer's disease. These actions are followed by post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
干预措施: Biomarker Disclosure Protocol (Behavioral)
Diagnostic Disclosure
Personalized disclosure on cognitive test results and research diagnosis, plus post-disclosure dementia risk reduction counseling.
For reporting purposes those participants randomized to this condition are analyzed by biomarker status (positive/+ or negative/-).
干预措施: Diagnostic Disclosure Protocol (Behavioral)
结局指标
主要结局
Post-disclosure health behavior change as measured by the health behavior subscale score
时间窗: 6 months
Subscale is a part of the Stages of Change Interview. Respondents will rate seven items relating to behavioral changes they have made post-disclosure on a Likert scale ranging from 1 = "I have not considered/am not interested in making this change" to 5 = "I have already made and maintained this change." Subscale score total ranges from 7 to 35 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the health communication subscale score
时间窗: 6 months
Subscale is a part of the Stages of Change Interview. Respondents will rate two items relating to health communication using a Likert scale. Subscale score total ranges from 2 to 10 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the research engagement subscale score
时间窗: 6 months
Subscale is a part of the Stages of Change Interview. Respondents will rate one item relating to research engagement on a Likert scale. Subscale score total ranges from 1 to 5 with higher scores indicating more engagement.
Post-disclosure health behavior change as measured by the advanced planning subscale score
时间窗: 6 months
Subscale is a part of the Stages of Change Interview. Respondents will rate seven items relating to advanced planning using a Likert Scale. Subscale score total ranges from 7 to 35 with higher scores indicating more engagement.
Percent participant retention in University of Michigan Memory and Aging Project (UMMAP) study
时间窗: Up to 24 months
Measured by attendance at study visits
次要结局
未报告次要终点
研究者
Annalise Rahman-Filipiak
Assistant Professor of Psychiatry
University of Michigan