Enhancing Consent for Alzheimer's Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Appreciation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of an enhanced consent procedure for patients with mild-to-moderate Alzheimer disease, and to identify factors and patient characteristics that predict the degree to which enhanced consent is more beneficial than routine consent procedures.
详细描述
Alzheimer disease can impair the capacity of patients to give informed consent for research participation. Studies of informed consent involving other patient populations suggest better understanding of consent-relevant information may be achieved through modifications in the consent delivery process, including incorporation of multimedia learning tools into the consent discussion.
In the present study, participants with Alzheimer disease and age-comparable healthy participants will be randomly assigned to review a hypothetical research protocol via routine or enhanced consent procedures. Participants will also complete standard cognitive and other rating scales so that we can characterize the sample, as well as evaluate the degree to which specific characteristics may be associated with need for enhanced consent procedures. Advances in the methods to optimize the informed consent process should enable future research participants to make more fully informed decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of mild to moderate possible or probable AD or demographically comparable healthy comparison subjects
- •Fluency in English
- •50 yrs and older
- •Informed written consent (or written assent with consent from legally authorized representative)
排除标准
- •Diagnosis of Lewy Body Dementia or Mild Cognitive Impairment
- •MMSE less than 15
- •Physical or medical conditions that preclude participants from completing tasks
- •Healthy comparison volunteers if they have a known neurologic or psychiatric condition that could impair neurocognitive functioning
结局指标
主要结局
Appreciation
时间窗: Within session - immediately following administration of the MacCAT-CR Understanding subscale
MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Appreciation subscale Minimum score = 0, Maximum Score = 6; Higher scores represent better understanding
Level of Understanding
时间窗: Within session - administered approximately 2-3 minutes after completion of the simulated consent process.
Modified version of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Understanding subscale. Minimum value = 0, Maximum value = 26; higher scores represent better performance
Reasoning
时间窗: Within session-immediately following administration of the MacCAT-CR Appreciation subscale
Reasoning subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) Minimum score = 0; Maximum Score = 8; Higher scores mean better reasoning capacity
Expression of a Choice
时间窗: Within session--immediately following administration of the MacCAT-CR Reasoning subscale
Expression of a Choice subscale of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR); Minimum score = 0, Maximum score = 2; higher scores represent more intact ability to express a clear choice
次要结局
- Level of Satisfaction With Consent Process(Within session)
- Expressed Willingness to Participate in the Hypothetical Protocol(Within session-last item of the Expression of a Choice Subscale, which itself was measured immediately after the MacCAT-CR Reasoning subscale)
研究者
Barton W. Palmer, Ph.D.
Professor
University of California, San Diego