NCT01045629

Brief Summary

The goal of this research is to understand whether schizophrenic patients are capable of comprehending clinical trial consent form or influenced by disease, also after intensified educational illustration for "understanding of consent form", their comprehension increased or not, in order to protect patient's right.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

January 6, 2010

Last Update Submit

January 13, 2010

Conditions

Keywords

schizophreniaPANSS

Study Arms (2)

SchizoComp

Competence Ability of schizophrenia

Other: Consent form education

NonSchizoComp

Competence of Non-schizophrenia

Interventions

Randomly stratified schizophrenic patients group, some receive consent form education, the others not.

SchizoComp

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Schizophrenic patients and control; PANSS score; Macarthur comprehension evaluation tool-clinical research Ed.

You may qualify if:

  • Experimental group
  • Age between 20 to 60, all genders.
  • Psychiatry doctor diagnosed who met DSMIV-TR criteria schizophrenia.
  • Participants require adequate ability to have a interview about 60-70min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).
  • Control group
  • Age between 20 to 60, all genders.
  • Psychiatry doctor diagnosed who exclude DSMIV-TR axis. I and II.
  • Participants require adequate ability to have a interview about 30min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

You may not qualify if:

  • Experimental group and control group
  • Participants have no adequate ability to have a interview about 60-70min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Tsuo-Hung Lan, MD., PhD.

    Taichung Veterans General Hospital

    STUDY DIRECTOR
  • Tsuo-Hung Lan, MD.,PhD

    Taichung Veterans General Hospital

    STUDY DIRECTOR

Central Study Contacts

Tsuo-Hung Lan, MD., PhD.

CONTACT

Yuan-Feng Chang, MD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 11, 2010

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations