Comparison of Video Consent and Routine Consent for Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 2
- 主要终点
- Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
研究概览
简要总结
The purpose of this study is to examine a novel technique for improving the informed consent process for participation in research by the older psychiatric population.
详细描述
This study will test a new method of delivering informed consent procedures to people with schizophrenia. The study has two aims. First, it will examine the impact of a multimedia DVD-based informed consent process on the ability of participants to make decisions regarding participation in research, both after the initial presentation of information and after 1 month. Second, it will examine the association between participant personal characteristics and the benefit derived from the DVD-based informed consent process.
Participants with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or an enhanced, DVD-based informed consent procedure. The outcome measure, comprehension of the consent materials, including understanding of the risks and benefits of participating in the study, will be assessed in each group. It is expected that the normal control group will reach the requisite level of comprehension faster than the schizophrenia group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
- •Fluency in English
- •Written informed consent
排除标准
- •Known or suspected dementia
研究组 & 干预措施
DVD patient high risk
Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
干预措施: DVD Consent (Other)
DVD patient low risk
Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
干预措施: DVD Consent (Other)
DVD normal high risk
Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
干预措施: DVD Consent (Other)
DVD normal low risk
Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
干预措施: DVD Consent (Other)
Routine control high risk
Participants with no psychiatric diagnosis randomized to routine consent, high risk version
干预措施: Routine Control (Other)
Routine control low risk
Participants with no psychiatric diagnosis randomized to routine consent, low risk version
干预措施: Routine Control (Other)
Routine patient low risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
干预措施: Routine Control (Other)
Routine patient high risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
干预措施: DVD Consent (Other)
Routine patient high risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
干预措施: Routine Control (Other)
结局指标
主要结局
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
时间窗: Measured at 1-month follow-up
次要结局
- Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure(Measured at 1-month follow-up)
研究者
Dilip V. Jeste
Professor
University of California, San Diego