Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
Recruitment status was Active, not recruiting
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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 |
- 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 ]
- 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 |
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 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 May 16, 2013