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

University of California San Diego

Status: Completed

Conditions: Schizophrenia

Treatments: Other: DVD Consent; Other: Routine Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00430391

R01MH067902 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 382 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

382 participants in 8 patient groups

DVD patient high risk

Experimental group

Description:

Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version

Treatment:

Other: DVD Consent

DVD patient low risk

Experimental group

Description:

Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version

Treatment:

Other: DVD Consent

DVD normal high risk

Experimental group

Description:

Participants with no psychiatric diagnosis randomized to DVD consent, high risk version

Treatment:

Other: DVD Consent

DVD normal low risk

Experimental group

Description:

Participants with no psychiatric diagnosis randomized to DVD consent, low risk version

Treatment:

Other: DVD Consent

Routine control high risk

Experimental group

Description:

Participants with no psychiatric diagnosis randomized to routine consent, high risk version

Treatment:

Other: Routine Control

Routine control low risk

Experimental group

Description:

Participants with no psychiatric diagnosis randomized to routine consent, low risk version

Treatment:

Other: Routine Control

Routine patient low risk

Experimental group

Description:

Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version

Treatment:

Other: Routine Control

Routine patient high risk

Experimental group

Description:

Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version

Treatment:

Other: DVD Consent

Other: Routine Control