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Competence Ability Study in People With Schizophrenia (CompSchizo)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01045629
First received: January 6, 2010
Last updated: January 13, 2010
Last verified: January 2010

January 6, 2010
January 13, 2010
October 2009
June 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01045629 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Competence Ability Study in People With Schizophrenia
Competence Ability Study in People With Schizophrenia

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.

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 will increase or not, in order to protect patient's right. First week, inform the patient a putative goal and method of clinical trial medicine research, then using Macarthur comprehension evaluation tool-clinical research Ed., evaluate the understanding of all patients for this putative clinical trial research consent form. For experimental group schizophrenic patients, using PANSS score evaluate seriousness of their symptom. 2 weeks later, randomly stratify schizophrenic patients into 2 groups, one give educational intervention for consent form, the other does not, then evaluate again with Macarthur comprehension evaluation tool-clinical research Ed. and PANSS score.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

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

  • Schizophrenia
  • Competence
Other: Consent form education
Randomly stratified schizophrenic patients group, some receive consent form education, the others not.
  • SchizoComp
    Competence Ability of schizophrenia
    Intervention: Other: Consent form education
  • NonSchizoComp
    Competence of Non-schizophrenia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Experimental group

  1. Age between 20 to 60, all genders.
  2. Psychiatry doctor diagnosed who met DSMIV-TR criteria schizophrenia.
  3. Participants require adequate ability to have a interview about 60-70min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

Control group

  1. Age between 20 to 60, all genders.
  2. Psychiatry doctor diagnosed who exclude DSMIV-TR axis. I and II.
  3. Participants require adequate ability to have a interview about 30min (include PANSS and Macarthur comprehension evaluation tool-clinical research Ed.).

Exclusion Criteria:

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.).

Both
20 Years to 65 Years
Yes
Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460 tosafish@hotmail.com
Contact: Yuan-Feng Chang, MD. 04-23592525 ext 3404
Taiwan
 
NCT01045629
C09080
Yes
IRB TCVGH, Taichung Veterans General Hospital
Taichung Veterans General Hospital
Not Provided
Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital
Study Director: Tsuo-Hung Lan, MD.,PhD Taichung Veterans General Hospital
Taichung Veterans General Hospital
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP