Effect of education during discharge on quality of life in patients with schizophrenia.
Design
Two arm parallel group randomized trial with control group
Settings and conduct
Imam Jafar Sadegh Psychiatric Hospital, Yazd Province
Participants/Inclusion and exclusion criteria
Patient with Schizophernia
Intervention groups
In this study, patients (in two cases and control groups and 32 preseason in each group) with schizophrenia were admitted to the comprehensive psychiatric center of Yazd province were studied. For the test group, in addition to routine programs, the discharge program was performed for 6 hours in the hospital and a routine program was performed for the control group.
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038614N1
Registration date:2018-05-21, 1397/02/31
Registration timing:prospective
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
Atena Dadgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3235 8700
Email address
a.dadgari30@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
empty
Scientific title
Effect of education during discharge on quality of life in patients with schizophrenia
Public title
Effect of education during discharge
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with schizophrenia
There is no record of training in this regard.
The patient is living with his wife, family or relatives.
Start at least 2 years from the start of the disease.
Have literacy to read and write.
His focus and attention is such that he can answer questions
Exclusion criteria:
The patient has neurological disorders or mental retardation.
The patient has alcohol and substance abuse
Detection of their type of disorder during the conduct of the examination.
During the research, there is an unexpected stressful event in the family
The patient has delusion and Hallucination
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In the research process, initially, patients with entry conditions based on the random allocation table in the test and control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoghi University
Street address
Sadughi Blvd, Bahonar Square
City
یزد
Province
Yazd
Postal code
8915173160
Approval date
2016-01-16, 1394/10/26
Ethics committee reference number
ir.ssu.rec.1394.40
Health conditions studied
1
Description of health condition studied
petient with schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Schizophrenic Quality Of Life
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the day of discharge, the group was asked to complete the demographic and quality of life questionnaire and on the day of discharge, the intervention program was administered to the patients in the intervention group. . The program included 6 hours of training, which was divided into 3 sessions of 2 hours, 2 hours by nurse, 2 hours second by occupational therapy and 2 hours by psychologist. The patient participated in these meetings with a family member
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Psychiatric Center of Yazd Province
Full name of responsible person
Ghasem Dastgerdi
Street address
ُُShahid Beheshti Blvd. Taft
City
Yazd
Province
Yazd
Postal code
8815273162
Phone
+98 35 3263 2005
Fax
+98 35 3263 2003
Email
a.dadgari30@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hasan Salari
Street address
Bu ali Street,
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3824 1751
Email
H.salari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atena Dadgari
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 349, soroosh Ave, Motahari Blvd
City
Yazd
Province
Yazd
Postal code
2558847758
Phone
+98 32350736
Email
A.dadgari30@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atena Dadgari
Position
ّّFaculty Member
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No346, soroosh street, Motahari Blvd
City
Yazd
Province
Yazd
Postal code
2558847758
Phone
+98 35 3522 1860
Email
A.dadgari30@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atena Dadgari
Position
ّّFaculty Member
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 346, soroosh street, Motahari Blvd
City
Yazd
Province
Yazd
Postal code
2558847758
Phone
+98 35 3522 1860
Email
A.dadgri30@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main consequence of sharing is possible
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers at academic and academic institutions have access to documentation
Under which criteria data/document could be used
To do research
From where data/document is obtainable
a.dadgari30@gmail.com
What processes are involved for a request to access data/document