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Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
This study is currently recruiting participants.
Study NCT00430391   Information provided by National Institute of Mental Health (NIMH)
First Received: January 31, 2007   Last Updated: April 10, 2009   History of Changes

January 31, 2007
April 10, 2009
December 2003
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00430391 on ClinicalTrials.gov Archive Site
Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure [ Time Frame: Measured at 1-month follow-up ] [ Designated as safety issue: No ]
Same as current
 
Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Comparison of Video Consent and Routine Consent for Research

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.

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.

 
Interventional
Other, Randomized, Open Label, Parallel Assignment, Efficacy Study
Schizophrenia
  • Other: DVD Consent
  • Other: Routine Control
  • Experimental: Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
  • Experimental: Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
  • Experimental: Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
  • Experimental: Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
  • No Intervention: Participants with no psychiatric diagnosis randomized to routine consent, high risk version
  • No Intervention: Participants with no psychiatric diagnosis randomized to routine consent, low risk version
  • No Intervention: Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
  • No Intervention: Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
382
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact: Danielle Glorioso, MSW 858-642-3902 dkukene@ucsd.edu
United States
 
NCT00430391
Dilip V. Jeste, MD, University of California, San Diego
R01 MH067902
National Institute of Mental Health (NIMH)
 
Principal Investigator: Dilip V. Jeste, MD UCSD
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP