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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
History of Changes
  Purpose

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.


Condition Intervention
Schizophrenia
Competence
 Other: Consent form education

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Competence Ability Study in People With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SchizoComp
Competence Ability of schizophrenia
 Other: Consent form education
Randomly stratified schizophrenic patients group, some receive consent form education, the others not.
NonSchizoComp
Competence of Non-schizophrenia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045629

Contacts
Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460 tosafish@hotmail.com
Contact: Yuan-Feng Chang, MD. 04-23592525 ext 3404

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Tsuo-Hung Lan, MD., PhD.     886-4-23592525 ext 3460     tosafish@hotmail.com    
Contact: Yuan-Feng Chang, MD.     886-4-23592525 ext 3404        
Sub-Investigator: Yuan-Feng Chang, MD.            
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Study Director: Tsuo-Hung Lan, MD., PhD. Taichung Veterans General Hospital
Study Director: Tsuo-Hung Lan, MD.,PhD Taichung Veterans General Hospital
  More Information

No publications provided

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01045629     History of Changes
Other Study ID Numbers: C09080
Study First Received: January 6, 2010
Last Updated: January 13, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
schizophrenia
PANSS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013