Comparison of Video Consent Versus Routine Consent for Participation in Research Studies

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dilip V. Jeste, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00430391
First received: January 31, 2007
Last updated: June 18, 2013
Last verified: January 2011

January 31, 2007
June 18, 2013
December 2003
February 2010   (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 ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Schizophrenia
  • Other: DVD Consent
    Participants are randomized to DVD enhanced consent that is either high risk or low risk.
  • Other: Routine Control
    Participants are assigned to the routine, standard consent.
  • Experimental: DVD patient high risk
    Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
    Intervention: Other: DVD Consent
  • Experimental: DVD patient low risk
    Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
    Intervention: Other: DVD Consent
  • Experimental: DVD normal high risk
    Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
    Intervention: Other: DVD Consent
  • Experimental: DVD normal low risk
    Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
    Intervention: Other: DVD Consent
  • Experimental: Routine control high risk
    Participants with no psychiatric diagnosis randomized to routine consent, high risk version
    Intervention: Other: Routine Control
  • Experimental: Routine control low risk
    Participants with no psychiatric diagnosis randomized to routine consent, low risk version
    Intervention: Other: Routine Control
  • Experimental: Routine patient low risk
    Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
    Intervention: Other: Routine Control
  • Experimental: Routine patient high risk
    Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
    Interventions:
    • Other: DVD Consent
    • Other: Routine Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
382
February 2010
February 2010   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00430391
R01 MH067902, R01MH067902
Yes
Dilip V. Jeste, University of California, San Diego
University of California, San Diego
National Institute of Mental Health (NIMH)
Principal Investigator: Dilip V. Jeste, MD UCSD
University of California, San Diego
January 2011

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