Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00430391
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2007-01-31
Brief Title:
Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Comparison of Video Consent and Routine Consent for Research
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH067902 | NIH | None | httpsreporternihgovquickSearchR01MH067902 |