Competence, Schizophrenia
Conditions
Keywords
schizophrenia, PANSS
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.
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.
Interventions
OTHERConsent form education
Randomly stratified schizophrenic patients group, some receive consent form education, the others not.
Sponsors
Taichung Veterans General Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.).
Countries
Taiwan
Contacts
Primary ContactTsuo-Hung Lan, MD., PhD.
Backup ContactYuan-Feng Chang, MD.
Outcome results
None listed