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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01045629
Other study ID # C09080
Secondary ID
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


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, 

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