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

Comparison of Video Consent and Routine Consent for Research

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430391

Enrollment

382

Registered

2007-02-01

Start date

2003-12-31

Completion date

2010-02-28

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

DVD, Multi-media, Schizophrenia, Normal Comparison, Consent procedures

Brief summary

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

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.

Interventions

OTHERDVD Consent

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

OTHERRoutine Control

Participants are assigned to the routine, standard consent.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026