Protocol summary

Summary
Objectives: Determination of effect of family-centered empowerment program on prevention of rehospitalization of the patient with schizophrenia Design: Interventional study , clinical trial Setting and conduct: For Case group will perform empowerment program in 6 sessions with 90 minutes length in each week . At end of sessions the case group was evaluated . Then two groups was checked for rehospitalization in 6 months . Participants including major eligibility criteria : 160 (80 patients and 80 family members )80 case group and 80 control group Inclusion criteria : Satisfaction for participate in study ; Schizophrenia is diagnosed to based on DSM-IV-TR criteria ; Patient is no MR : Patient tendering is main tendering and minimum is 15 years old ; Patient tendering is life with patient ; patient and family previously no participated in any educational groups ; Exclusion criteria : Unwillingness of samples for continue of participation in educational sessions ; Patient is suffered of serious illness during the study Intervention: Perform family-centered empowerment program in four stages : 1- Perceived threat 2- Promotion of self efficacy 3- Instructional participation 4- Evaluation of program main outcome measures (variables): rehospitalization in 6 months after intervention

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT201204059384N1
Registration date: 2013-04-23, 1392/02/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-23, 1392/02/03
Registrant information
Name
Alireza Rezaie Torkselouie
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 338 8522
Email address
rezaie@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences , Vice chancellor for development of research and technology
Expected recruitment start date
2012-02-09, 1390/11/20
Expected recruitment end date
2012-06-07, 1391/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment program on prevention of rehospitalization of the patient with schizophrenia.
Public title
The effect of family-centered empowerment program on prevention of rehospitalization of the patient with schizophrenia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Satisfaction of patient and family for participate in study ; Schizophrenia is diagnosed by psychiatrist based on DSM-IV-TR criteria ; Patient is no MR ; Patient tendering is main tendering and minimum is 15 years old ; Patient tendering is life with patient ; patient and family previously no participated in any educational groups ; Exclusion criteria : Unwillingness of samples for continue of participation in educational sessions ; Patient is suffered of serious illness during the study
Age
From 15 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Siences , Vice Chancellor for Research , po box 45 , City of University , Golestan Ave
City
Ahvaz
Postal code
Approval date
2012-02-04, 1390/11/15
Ethics committee reference number
396-ETH

Health conditions studied

1

Description of health condition studied
Schizophrenia
ICD-10 code
f20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Rehospitalization
Timepoint
6 months after intervention
Method of measurement
Family Report

Secondary outcomes

1

Description
Knowledge of Family
Timepoint
Before and After Intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Case Group : Case group( 40 samples ) divided in two groups . Family-centered empowerment program is performed for each 20 samples ( 10 patient and 10 family member )in 6 sessions with 90 minutes length in each week . Sessions are performed with lecture and question-answer method . At end of each session pamphlets of content of same session will provided to patient and family . In this study for better to be held of session will used of a MSN of health education . At end of sessions the case group will evaluated . Then two groups will checked for rehospitalization in 6 months .
Category
Prevention

2

Description
Control Group : For control group not performed empowerment program and only will used routine care .Control group Like case group will checked for rehospitalization in 6 months .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebnesina Hospital
Full name of responsible person
Dr Ghanizadeh
Street address
Hafez Street near 13 Aban Park
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences , Vice Chancellor for Development of Research
Full name of responsible person
DR Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences , Vice Chancellor for Development of Research and Technology , City of University , po box 45 , Golestan Ave
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences , Vice Chancellor for Development of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Bahman Dashtbozorgi
Position
Guide/MSN Psychiatric Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences , School of Nursing , City of University , Golestan Ave
City
Ahvaz
Postal code
6138858381
Phone
+98 61 1373 8301
Fax
+98 61 1373 8301
Email
bahnurse@ajums.ac.ir ; bahnurse@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Bahman Dashtbozorgi
Position
Guide/MSN Psychiatric Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences , School of Nursing , City of University , Golestan Ave
City
Ahvaz
Postal code
6138858381
Phone
+98 61 1373 8301
Fax
+98 61 1373 8301
Email
bahnurse@ajums.ac.ir ; bahnurse@yahoo.com
Web page address
www.ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Bahman Dashtbozorgi
Position
Guide/MSN Psychiatric Nursing
Other areas of specialty/work
Street address
-Ahvaz Jundishapur University of Medical Sciences , School of nursing , City of University , Golestan Ave
City
Ahvaz
Postal code
6138858381
Phone
+98 61 1373 8301
Fax
+98 61 1373 8301
Email
bahnurse@ajums.ac.ir ; bahnurse@yahoo.com ; bahman.dashtbozorgi@gmail.com
Web page address
www.ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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