Comparison of Video Consent Versus Routine Consent for Participation in Research Studies - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2007

Last Updated Date

April 10, 2009

Start Date ^ICMJE

December 2003

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00430391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Other: DVD Consent
Other: Routine Control

Study Arms / Comparison Groups

Experimental: Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
Experimental: Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
Experimental: Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
Experimental: Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
No Intervention: Participants with no psychiatric diagnosis randomized to routine consent, high risk version
No Intervention: Participants with no psychiatric diagnosis randomized to routine consent, low risk version
No Intervention: Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
No Intervention: Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

382

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Danielle Glorioso, MSW

858-642-3902

dkukene@ucsd.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00430391

Responsible Party

Dilip V. Jeste, MD, University of California, San Diego

Study ID Numbers ^ICMJE

R01 MH067902

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Dilip V. Jeste, MD

UCSD

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

April 2009

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