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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Official Title:	Comparison of Video Consent and Routine Consent for Research

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
No Intervention: 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.
No Intervention: 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.
No Intervention: 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.
No Intervention: Routine patient high risk 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:

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.

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

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dilip V. Jeste, MD

UCSD

More Information

No publications provided

Responsible Party:	Dilip V. Jeste, MD, University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00430391 History of Changes
Other Study ID Numbers:	R01 MH067902
Study First Received:	January 31, 2007
Last Updated:	January 7, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

DVD
Multi-media
Schizophrenia
Normal Comparison
Consent procedures

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012