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Completed

NCT Number: NCT00430391

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92161, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DVD Consent

Other

Participants are randomized to DVD enhanced consent that is either high risk or low risk.

Routine Control

Other

Participants are assigned to the routine, standard consent.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Comparison of Video Consent and Routine Consent for Research

Important dates

Study start
2003
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2007
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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