Competence Ability Study in People With Schizophrenia

• Conditions: Schizophrenia; Competence
• Interventions: Other: Consent form education

• Registration Number: NCT01045629
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2009-10
• Status Verified: 2010-01
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SchizoComp	Consent form education	Competence Ability of schizophrenia

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung City, Taiwan