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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00430391 |
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 |
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Schizophrenia |
Other: DVD Consent Other: Routine Control |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Video Consent and Routine Consent for Research |
Estimated Enrollment: | 382 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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DVD patient high risk: Experimental
Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
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Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
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DVD patient low risk: Experimental
Patient with a diagnosis of schizophrenia/schizoaffetive disorder randomized to DVD consent, low risk version
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Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
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DVD normal high risk: Experimental
Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
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Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
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DVD normal low risk: Experimental
Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
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Other: DVD Consent
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
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Routine control high risk: No Intervention
Participants with no psychiatric diagnosis randomized to routine consent, high risk version
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Other: Routine Control
Participants are assigned to the routine, standard consent.
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Routine control low risk: No Intervention
Participants with no psychiatric diagnosis randomized to routine consent, low risk version
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Other: Routine Control
Participants are assigned to the routine, standard consent.
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Routine patient low risk: No Intervention
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
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Other: Routine Control
Participants are assigned to the routine, standard consent.
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Routine patient high risk: No Intervention
Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
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Other: Routine Control
Participants are assigned to the routine, standard consent.
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Patients with schizophrenia and a normal comparison group will participate in either a routinely used informed consent procedure or a novel, enhanced 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.
Aim 1: To examine the impact of a multimedia DVD-based informed consent process on the decisional capacity for participation in a research treatment protocol immediately after presentation of the information as well as one month later.
Hypothesis 1: Immediately after presentation of the consent information, participants provided with the enhanced DVD consent procedure will demonstrate (across the two subject groups and the lower- and higher-risk protocols) better understanding, appreciation, reasoning, and expression of choice for participation in the research protocol as well as greater satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The enhanced DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.
Hypothesis 2: One month after the baseline testing, participants provided with the enhanced DVD consent procedure will demonstrate (across the two diagnostic groups and the lower- and higher-risk protocols) greater stability of decisional capacity as well as greater stability of satisfaction with the consent procedure compared to participants presented with the routine consent procedure. The DVD consent procedure will be most beneficial for patients with schizophrenia in higher-risk protocol and least beneficial for normal controls in lower-risk protocol.
Aim 2: To examine, among middle-aged and elderly individuals with schizophrenia and normal comparison subjects, the association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure.
Hypothesis 3: Effectiveness of DVD consent format will be a function of specific subject demographic, clinical, and cognitive characteristics that are associated with decisional capacity. In particular the following factors will be associated with greater benefit of DVD consent compared to routine paper consent format: Older age, diagnosis of schizophrenia, dependent living situation, severity of negative and depressive symptoms, and cognitive impairment (specifically on tests of attention/ working memory, short-term memory, and certain executive functions.)
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Danielle Glorioso, MSW | 858-642-3902 | dkukene@ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Danielle Glorioso, BS 895-642-3902 dkukene@ucsd.edu | |
Sub-Investigator: Barton Palmer, PhD |
Principal Investigator: | Dilip V. Jeste, MD | UCSD |
Responsible Party: | University of California, San Diego ( Dilip V. Jeste, MD ) |
Study ID Numbers: | R01 MH067902 |
Study First Received: | January 31, 2007 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00430391 |
Health Authority: | United States: Federal Government |
DVD Multi-media Schizophrenia Normal Comparison Consent procedures |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |