Clinical trial NCT01045629: Competence Ability Study in People With Schizophrenia
Official title: Competence Ability Study in People With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Competence
Keywords: schizophrenia
PANSS
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenic patients and control; PANSS score; Macarthur comprehension evaluation tool-clinical research Ed.

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.

Eligibility criteria: 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.).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Tsuo-Hung Lan, MD., PhD.
role: STUDY_DIRECTOR
affiliation: Taichung Veterans General Hospital
name: Tsuo-Hung Lan, MD.,PhD
role: STUDY_DIRECTOR
References: