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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Video Consent and Routine Consent for Research

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: DVD Consent
* Other: Routine Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVD patient high risk<br>Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version | Other: DVD Consent<br>* Participants are randomized to DVD enhanced consent that is either high risk or low risk.<br>|
| Experimental: DVD patient low risk<br>Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version | Other: DVD Consent<br>* Participants are randomized to DVD enhanced consent that is either high risk or low risk.<br>|
| Experimental: DVD normal high risk<br>Participants with no psychiatric diagnosis randomized to DVD consent, high risk version | Other: DVD Consent<br>* Participants are randomized to DVD enhanced consent that is either high risk or low risk.<br>|
| Experimental: DVD normal low risk<br>Participants with no psychiatric diagnosis randomized to DVD consent, low risk version | Other: DVD Consent<br>* Participants are randomized to DVD enhanced consent that is either high risk or low risk.<br>|
| Experimental: Routine control high risk<br>Participants with no psychiatric diagnosis randomized to routine consent, high risk version | Other: Routine Control<br>* Participants are assigned to the routine, standard consent.<br>|
| Experimental: Routine control low risk<br>Participants with no psychiatric diagnosis randomized to routine consent, low risk version | Other: Routine Control<br>* Participants are assigned to the routine, standard consent.<br>|
| Experimental: Routine patient low risk<br>Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version | Other: Routine Control<br>* Participants are assigned to the routine, standard consent.<br>|
| Experimental: Routine patient high risk<br>Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version | Other: DVD Consent<br>* Participants are randomized to DVD enhanced consent that is either high risk or low risk.<br>Other: Routine Control<br>* Participants are assigned to the routine, standard consent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DVD, Multi-media, Schizophrenia, Normal Comparison, Consent procedures