Competence Ability Study in People With Schizophrenia

Schizophrenia Clinical Trial

— CompSchizo  

Official title:

Competence Ability Study in People With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01045629
• Other study ID #: C09080
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2010
• Last updated: January 13, 2010
• Start date: October 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: Taichung Veterans General Hospital
• Contact: Tsuo-Hung Lan, MD., PhD.
• Phone: 04-23592525
• Email: tosafish[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Competence
• Schizophrenia

Intervention

Other:
• Consent form education
Randomly stratified schizophrenic patients group, some receive consent form education, the others not.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan,