Competence Ability Study in People With Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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 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

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Schizophrenia Competence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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SchizoComp

Competence Ability of schizophrenia

Consent form education

Intervention Type OTHER

Randomly stratified schizophrenic patients group, some receive consent form education, the others not.

NonSchizoComp

Competence of Non-schizophrenia

No interventions assigned to this group

Interventions

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Consent form education

Randomly stratified schizophrenic patients group, some receive consent form education, the others not.

Intervention Type OTHER

Eligibility Criteria

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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.).

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes