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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2010-02-28

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.

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

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DVD Consent

Participants are randomized to DVD enhanced consent that is either high risk or low risk.

Intervention Type OTHER

Routine Control

Participants are assigned to the routine, standard consent.

Intervention Type OTHER

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