Competence Ability Study in People With Schizophrenia (CompSchizo)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Competence Ability Study in People With Schizophrenia|
|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)|
Competence Ability of schizophrenia
Other: Consent form education
Randomly stratified schizophrenic patients group, some receive consent form education, the others not.
Competence of Non-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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045629
|Contact: Tsuo-Hung Lan, MD., PhD.||04-23592525 ext firstname.lastname@example.org|
|Contact: Yuan-Feng Chang, MD.||04-23592525 ext 3404|
|Taichung Veterans General Hospital||Recruiting|
|Taichung City, Taiwan, 40705|
|Contact: Tsuo-Hung Lan, MD., PhD. 886-4-23592525 ext 3460 email@example.com|
|Contact: Yuan-Feng Chang, MD. 886-4-23592525 ext 3404|
|Sub-Investigator: Yuan-Feng Chang, MD.|
|Study Director:||Tsuo-Hung Lan, MD., PhD.||Taichung Veterans General Hospital|
|Study Director:||Tsuo-Hung Lan, MD.,PhD||Taichung Veterans General Hospital|