SchizophreniaNCT00430391
Comparison of Video Consent Versus Routine Consent for Participation in Research Studies
A study testing DVD Consent in people with Schizophrenia, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- DVD Consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
- Fluency in English
- Written informed consent
Who cannot join
- Known or suspected dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92161
About this study
Official title: Comparison of Video Consent and Routine Consent for Research
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- DVD Consent, Routine Control
- Keywords
- DVD, Multi-media, Schizophrenia, Normal Comparison, Consent procedures
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DVD ConsentOther
Participants are randomized to DVD enhanced consent that is either high risk or low risk.
Routine ControlOther
Participants are assigned to the routine, standard consent.
| Study group | Role | What they receive |
|---|---|---|
| DVD patient high risk | Experimental | Patients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version Receives: Other: DVD Consent |
| DVD patient low risk | Experimental | Patient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version Receives: Other: DVD Consent |
| DVD normal high risk | Experimental | Participants with no psychiatric diagnosis randomized to DVD consent, high risk version Receives: Other: DVD Consent |
| DVD normal low risk | Experimental | Participants with no psychiatric diagnosis randomized to DVD consent, low risk version Receives: Other: DVD Consent |
| Routine control high risk | Experimental | Participants with no psychiatric diagnosis randomized to routine consent, high risk version Receives: Other: Routine Control |
| Routine control low risk | Experimental | Participants with no psychiatric diagnosis randomized to routine consent, low risk version Receives: Other: Routine Control |
| Routine patient low risk | Experimental | Participants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version Receives: Other: Routine Control |
| Routine patient high risk | Experimental | Participants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version Receives: Other: DVD Consent; Other: Routine Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
Measured: 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: Measured at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startDec 2003
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dilip V. Jeste, University of California, San Diego
- Investigators
- Dilip V. Jeste, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430391
- Sponsor's protocol ID
- R01MH067902
- Other IDs
- R01MH067902
- Status last verified
- Jan 2011
- First submitted
- 31 Jan 2007
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Consent and Routine Consent for Research
- ClinicalTrials.gov ID
- NCT00430391
- Acronym / sponsor ID
- R01MH067902
- Conditions
- Schizophrenia
- Keywords
- DVD, Multi-media, Schizophrenia, Normal Comparison, Consent procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2003
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| DVD patient high risk | Experimental | Other: DVD ConsentPatients with a diagnosis of schizophrenia/schizoaffective disorder randomized to the DVD, high risk version |
| DVD patient low risk | Experimental | Other: DVD ConsentPatient with a diagnosis of schizophrenia/schizoaffective disorder randomized to DVD consent, low risk version |
| DVD normal high risk | Experimental | Other: DVD ConsentParticipants with no psychiatric diagnosis randomized to DVD consent, high risk version |
| DVD normal low risk | Experimental | Other: DVD ConsentParticipants with no psychiatric diagnosis randomized to DVD consent, low risk version |
| Routine control high risk | Experimental | Other: Routine ControlParticipants with no psychiatric diagnosis randomized to routine consent, high risk version |
| Routine control low risk | Experimental | Other: Routine ControlParticipants with no psychiatric diagnosis randomized to routine consent, low risk version |
| Routine patient low risk | Experimental | Other: Routine ControlParticipants with schizophrenia/schizoaffective disorder randomized to routine consent, low risk version |
| Routine patient high risk | Experimental | Other: DVD Consent, Other: Routine ControlParticipants with schizophrenia/schizoaffective disorder randomized to routine consent, high risk version |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV diagnosis of schizophrenia or no current or past major neuropsychiatric disorder (normal subjects)
- Fluency in English
- Written informed consent
Key exclusion criteria (1 listed)
- Known or suspected dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DVD ConsentParticipants are randomized to DVD enhanced consent that is either high risk or low risk. | Other | DVD normal high risk, DVD normal low risk, DVD patient high risk, DVD patient low risk, Routine patient high risk |
| Routine ControlParticipants are assigned to the routine, standard consent. | Other | Routine control high risk, Routine control low risk, Routine patient high risk, Routine patient low risk |
Primary outcome
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study
Time frame: Measured at 1-month follow-up
1 secondary outcome
Association of subject characteristics with the degree of benefit derived from the DVD-based consent over routine consent procedure
Time frame: Measured at 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilip V. Jeste, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DVD Consent in people with Schizophrenia, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of the consent materials, including understanding of the risks and benefits of participating in the study (time frame: Measured at 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.