NCT00430391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Dec 2003

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 19, 2013

Status Verified

January 1, 2011

Enrollment Period

6.2 years

First QC Date

January 31, 2007

Last Update Submit

June 18, 2013

Conditions

Schizophrenia

Keywords

DVDMulti-mediaSchizophreniaNormal ComparisonConsent procedures

Outcome Measures

Primary Outcomes (1)

  • Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study

    Measured at 1-month follow-up

Secondary Outcomes (1)

  • 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

Study Arms (8)

DVD patient high risk

EXPERIMENTAL

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

Other: DVD Consent

DVD patient low risk

EXPERIMENTAL

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

Other: DVD Consent

DVD normal high risk

EXPERIMENTAL

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

Other: DVD Consent

DVD normal low risk

EXPERIMENTAL

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

Other: DVD Consent

Routine control high risk

EXPERIMENTAL

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

Other: Routine Control

Routine control low risk

EXPERIMENTAL

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

Other: Routine Control

Routine patient low risk

EXPERIMENTAL

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

Other: Routine Control

Routine patient high risk

EXPERIMENTAL

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

Other: DVD ConsentOther: Routine Control

Interventions

DVD ConsentOTHER

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

DVD normal high riskDVD normal low riskDVD patient high riskDVD patient low riskRoutine patient high risk
Routine ControlOTHER

Participants are assigned to the routine, standard consent.

Routine control high riskRoutine control low riskRoutine patient high riskRoutine patient low risk

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
  • Fluency in English
  • Written informed consent

You may not qualify if:

  • Known or suspected dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Dilip V. Jeste, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

December 1, 2003

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 19, 2013

Record last verified: 2011-01

Locations

US(1)