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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH067902 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVD patient high risk | Experimental | Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version |
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| DVD patient low risk | Experimental | Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version |
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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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| DVD normal low risk | Experimental | Participants with no psychiatric diagnosis randomized to DVD consent, low risk version |
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| Routine control high risk | Experimental | Participants with no psychiatric diagnosis randomized to routine consent, high risk version |
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| Routine control low risk |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVD Consent | Other | Participants are randomized to DVD enhanced consent that is either high risk or low risk. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study | Measured at 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure | Measured at 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dilip V. Jeste, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92161 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Participants with no psychiatric diagnosis randomized to routine consent, low risk version |
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| Routine patient low risk | Experimental | Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version |
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| Routine patient high risk | Experimental | Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version |
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| Routine Control | Other | Participants are assigned to the routine, standard consent. |
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