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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SchizoComp | Competence Ability of schizophrenia |
| |
| NonSchizoComp | Competence of Non-schizophrenia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consent form education | Other | Randomly stratified schizophrenic patients group, some receive consent form education, the others not. |
|
Inclusion Criteria:
Experimental group
Control group
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.).
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Schizophrenic patients and control; PANSS score; Macarthur comprehension evaluation tool-clinical research Ed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tsuo-Hung Lan, MD., PhD. | Contact | 04-23592525 | 3460 | tosafish@hotmail.com |
| Yuan-Feng Chang, MD. | Contact | 04-23592525 | 3404 |
| Name | Affiliation | Role |
|---|---|---|
| Tsuo-Hung Lan, MD., PhD. | Taichung Veterans General Hospital | Study Director |
| Tsuo-Hung Lan, MD.,PhD | Taichung Veterans General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Recruiting | Taichung | Taiwan | 40705 | Taiwan |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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