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

June 18, 2013 updated by: Dilip V. Jeste, University of California, San Diego

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DVD patient high risk
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.
Experimental: DVD patient low risk
Patient with a diagnosis of schizophrenia/schizoaffective 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.
Experimental: DVD normal high risk
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.
Experimental: DVD normal low risk
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.
Experimental: Routine control high risk
Participants with no psychiatric diagnosis randomized to routine consent, high risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Experimental: Routine control low risk
Participants with no psychiatric diagnosis randomized to routine consent, low risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Experimental: Routine patient low risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
Other: Routine Control
Participants are assigned to the routine, standard consent.
Experimental: Routine patient high risk
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measured at 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Measured at 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Dilip V. Jeste, MD, UCSD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH067902 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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