ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparison of Video Consent Versus Routine Consent for Participation in Research Studies

This study is currently recruiting participants.
Study NCT00430391.   Last updated on February 28, 2008.   Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Official Title † Comparison of Video Consent and Routine Consent for Research
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

Patients with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or a novel, enhanced 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.

Aim 1: To examine the impact of a multimedia DVD-based informed consent process on the decisional capacity for participation in a research treatment protocol immediately after presentation of the information as well as one month later.

Hypothesis 1: Immediately after presentation of the consent information, participants provided with the enhanced DVD consent procedure will demonstrate (across the two subject groups and the lower- and higher-risk protocols) better understanding, appreciation, reasoning, and expression of choice for participation in the research protocol as well as greater satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The enhanced DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.

Hypothesis 2: One month after the baseline testing, participants provided with the enhanced DVD consent procedure will demonstrate (across the two diagnostic groups and the lower- and higher-risk protocols) greater stability of decisional capacity as well as greater stability of satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.

Aim 2: To examine, among middle-aged and elderly individuals with schizophrenia and normal comparison subjects, the association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure.

Hypothesis 3: Effectiveness of DVD consent format will be a function of specific subject demographic, clinical, and cognitive characteristics that are associated with decisional capacity. In particular the following factors will be associated with greater benefit of DVD consent compared to routine paper consent format: Older age, diagnosis of schizophrenia, dependent living situation, severity of negative and depressive symptoms, and cognitive impairment (specifically on tests of attention/ working memory, short-term memory, and certain executive functions.)
Study Phase
Study Type † Interventional
Study Design † Other, Randomized, Open Label, Parallel Assignment, Efficacy Study
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 ]
Secondary Outcome Measure † 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 ]
Condition † Schizophrenia
Intervention † Other: DVD Consent
Other: Routine Control
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 382
Start Date † December 2003
Completion Date November 2008
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
Gender Both
Ages 40 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Danielle Glorioso, BS     858-642-3902     dkukene@ucsd.edu    
Location Countries † United States
Administrative Information Fields
NCT ID † NCT00430391
Organization ID R01 MH067902
Secondary IDs ††
Study Sponsor † National Institute of Mental Health (NIMH)
Collaborators ††
Investigators †
Principal Investigator:     Dilip V. Jeste, MD     UCSD    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date † January 31, 2007
Last Updated Date February 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act
U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services



Links to all studies - primarily for crawlers