Protocol summary

Summary
The aim of this study is to determine the effect of family psych education on the frequency of hospitalization in patients with schizophrenia in Razi Psychiatric Center in Urmia. Study design: An experimental study with two groups (control and intervention). Study population: Patients with schizophrenia in Razi Psychiatric Center in Urmia. Main inclusion criteria: The definitive diagnosis of schizophrenia, having history of at least one time readmission. Exclusion criteria: Absence at more than one session of the training classes. Sample size: 50 person, and random allocation to two groups of 50 people. The intervention: family psych education, 5 training sessions, twice a week, for three weeks, each class lasts 60 to 80 minutes, so that each class will be attending with 7-6 patient and their family, one of the active members. Primary outcomes: frequency of readmission.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080726347N4
Registration date: 2017-02-19, 1395/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-19, 1395/12/01
Registrant information
Name
Soheyla Ahangarzade Rezaei
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
rezaei.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family psycho-education on the frequency of readmission in patients with schizophrenia hospitalized in razi psychiatric center in Urmia 2016
Public title
The effect of family psycho-education on the frequency of readmission in patients with schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: The definitive diagnoses of schizophrenia; having history of at least one time readmission. Exclusion criteria: Absence at more than one session of the training classes.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran Urmia
City
Urmia
Postal code
5714783734
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
ir.umsu.rec.1395.124

Health conditions studied

1

Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Readmission
Timepoint
One, three and six months after the end of the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: family psych education; 5 training sessions, twice a week, for three weeks, each class is 60 to 80 minutes, so that each class will be attending with 7-6 patient and their his family, one of the active members.
Category
Treatment - Other

2

Description
Control group: The control group will receive no intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital of Urmia University of Medical Sciences
Full name of responsible person
Sina Nejaatpoor
Street address
Razi Hospital, Salmas Road, Urmia, I.R.IRAN
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Irag Mohabbi
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences
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
Urmia University of Medical Sciences
Full name of responsible person
Soheyla Ahangarzade Rezaei
Position
PHD
Other areas of specialty/work
Street address
Urmia Faculty of Nursing & Midwifery school, Pardis Nazlou, 11 km of Nazlou Road, Urmia
City
Urmia
Postal code
Phone
+98 984432754963
Fax
Email
nursing-college@umsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Faculty of Nursing & Midwifery school
Full name of responsible person
Hasan Jalilzadeh
Position
Master Student in Psychiatric Nursing
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road, Urmia, Iran
City
Urmia
Postal code
Phone
+98 914 807 3558
Fax
Email
www.h.jalilzadeh.nurse@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Hasan Jalilzadeh
Position
Master Student in Psychiatric Nursing
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road, Urmia, Iran
City
Urmia
Postal code
Phone
+98 914 807 3558
Fax
Email
h.jalilzadeh.nurse@gmail.com
Web page address

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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