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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Other: DVD Consent; Other: Routine Control

• Registration Number: NCT00430391
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-01
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine patient high risk	DVD Consent	Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version
DVD patient low risk	DVD Consent	Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version
DVD normal high risk	DVD Consent	Participants with no psychiatric diagnosis randomized to DVD consent, high risk version
DVD patient high risk	DVD Consent	Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version
DVD normal low risk	DVD Consent	Participants with no psychiatric diagnosis randomized to DVD consent, low risk version
Routine control high risk	Routine Control	Participants with no psychiatric diagnosis randomized to routine consent, high risk version
Routine control low risk	Routine Control	Participants with no psychiatric diagnosis randomized to routine consent, low risk version
Routine patient low risk	Routine Control	Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version
Routine patient high risk	Routine Control	Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States