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Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00430391
  Purpose

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.


Condition Intervention
Schizophrenia
Other: DVD Consent
Other: Routine Control

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Comparison of Video Consent and Routine Consent for Research

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 382
Study Start Date: December 2003
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
DVD patient high risk: Experimental
Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
DVD patient low risk: Experimental
Patient with a diagnosis of schizophrenia/schizoaffetive disorder randomized to DVD consent, low risk version
Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
DVD normal high risk: Experimental
Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
DVD normal low risk: Experimental
Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
Routine control high risk: No Intervention
Participants with no psychiatric diagnosis randomized to routine consent, high risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Routine control low risk: No Intervention
Participants with no psychiatric diagnosis randomized to routine consent, low risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Routine patient low risk: No Intervention
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Routine patient high risk: No Intervention
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.

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.)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430391

Contacts
Contact: Danielle Glorioso, MSW 858-642-3902 dkukene@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92161
Contact: Danielle Glorioso, BS     895-642-3902     dkukene@ucsd.edu    
Sub-Investigator: Barton Palmer, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Dilip V. Jeste, MD UCSD
  More Information

Responsible Party: University of California, San Diego ( Dilip V. Jeste, MD )
Study ID Numbers: R01 MH067902
Study First Received: January 31, 2007
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00430391  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
DVD
Multi-media
Schizophrenia
Normal Comparison
Consent procedures

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009