NCT01045629

Competence Ability Study in People With Schizophrenia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Taichung Veterans General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Schizophrenia
• Competence

Interventions

Type	Name	Description
OTHER	Consent form education	Randomly stratified schizophrenic patients group, some receive consent form education, the others not.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-01-11
• Last updated: 2010-01-14

Locations

1 site across 1 country: Taiwan