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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dilip V. Jeste, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00430391
First received: January 31, 2007
Last updated: June 18, 2013
Last verified: January 2011
  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:


Further study details as provided by University of California, San Diego:

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 ]

Enrollment: 382
Study Start Date: December 2003
Study Completion Date: February 2010
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.
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Diego
Investigators
Principal Investigator: Dilip V. Jeste, MD UCSD
  More Information

No publications provided

Responsible Party: Dilip V. Jeste, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00430391     History of Changes
Other Study ID Numbers: R01 MH067902, R01MH067902
Study First Received: January 31, 2007
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
DVD
Multi-media
Schizophrenia
Normal Comparison
Consent procedures

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 30, 2014