Comparison of Video Consent and Routine Consent for Research
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- University of California, San Diego
- Enrollment
- 382
- Locations
- 1
- Primary Endpoint
- Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Dilip V. Jeste
Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
- •Fluency in English
- •Written informed consent
Exclusion Criteria
- •Known or suspected dementia
Outcomes
Primary Outcomes
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
Time Frame: Measured at 1-month follow-up
Secondary Outcomes
- 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)