Protocol summary

Study aim
Determining the Effect of Peer-Based Education on the Functioning and Appointment of My Families in Schizophrenic Patients.
Design
Randomized controlled clinical trial.
Settings and conduct
Clinical trial. All family carers of schizophrenic patients admitted to psychiatric wards of the studied hospital
Participants/Inclusion and exclusion criteria
Entry requirements 1. Having ages 20 to 60 years. 2. Has the level of education below the diploma. 3. Having a common life with a schizophrenic patient. 4. Not known for mental illness. 5. The desire to participate in the study. 6. The history of schizophrenia. 7. Have free time to attend classes. 8. Resident of Tehran. 9. No hearing impairment and vision. 10. Not known for known mental illness. 11. Lack of history of drug use and history. 12. Lack of great crisis, such as the divorce and death of loved ones in the last six months. Exit criteria include: 1. Cancellation of the continuation of the study. 2. Having a person with a known mental illness during the study. 3. Two absentee sessions in class are considered to be out of the study. 4. The patient's care after experiencing the training process will experience "major stress", such as the divorce or death of one of the loved ones, until the post-test.
Intervention groups
The study ،population consisted of two groups of test and control group.
Main outcome variables
Barrow; function;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181218042040N1
Registration date: 2019-03-16, 1397/12/25
Registration timing: retrospective

Last update: 2019-03-16, 1397/12/25
Update count: 0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Behnaz Lami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2248 5410
Email address
behnazlami54@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer-centered education on the function and burden of family caregivers of Schizophrenic
Public title
" peer-centered education". the function and burden of family caregivers of Schizophrenic"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having ages 20 to 60 years. 2. Have a college degree. 3. Having a common life with schizophrenia.4. Not being diagnosed with mental illness.5. The desire to participate in the study .6. The history of hospitalization of schizophrenia.7. Have free time to attend classes. 8. Resident in Tehran .9. No hearing impairment and vision.10. Not known for mental illness. Lack of history of substance use and history .12. Lack of great crisis, such as the divorce and death of loved ones in the last six months
Exclusion criteria:
Canceling the continuation of the study .2. The person has a history of mental illness during the study.3. Two sessions of absenteeism in the classroom are excluded from the study. 4. The patient's care after experiencing the training process will experience "major stress", such as the divorce or death of one of the loved ones, until the post-test.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the Army Medical University
Street address
Tehran - West Fatemi St. - Shahid Etemadzadeh - Army University of Medical Sciences Tel: -6-86096350-021 Code: 1411718541.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
10200

Health conditions studied

1

Description of health condition studied
Family Guardians of Schizophrenia Patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
"The Impact of Breast Cancer on Family Caregivers of Schizophrenic Patients"
Timepoint
"Measurement of Barrowani at the time of study"
Method of measurement
Using the "Questionnaire for 22 Questions"

Secondary outcomes

1

Description
"Comparing the Effect of Peer-Based Education on the Functioning and Forgery of Family Carers"
Timepoint
Study "The Effect of Peer-Based Learning on Freedom of Exercise, In-Face Training in Two-Hour Sessions,"
Method of measurement
"66 questions questionnaire"

Intervention groups

1

Description
Intervention group:
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital 505 Army
Full name of responsible person
nahed rajaee
Street address
Tehran, Shariati avenue, opposite Bahar Shiraz, end of Kaj Street, Army Nursing Faculty
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6860 9635
Email
aja.nursing.journal@gmail.com
Web page address
http://nursing.ajaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
financial department
Street address
Tehran - West Fatemi St. - Shahid Etemadzadeh - Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6860 9635
Fax
+98 21 6860 9635
Email
aja.nursing.journal@gmail.com
Web page address
http://nursing.ajaums.ac.ir
Grant name
financial department
Grant code / Reference number
46544
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Amir Hussein Peshgooy
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Tehran, Shariati avenue, opposite Bahar Shiraz, end of Kaj Street, Army Nursing Faculty
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7750 0201
Email
apishgooie@yahoo.com
Web page address
http://nursing.ajaums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nahid Rajaee
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Tehran, Shariati avenue, opposite Bahar Shiraz, end of Kaj Street, Army Nursing Faculty
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7750 0201
Email
n.ragai96@yahoo.com
Web page address
http://nursing.ajaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Hengameh Habibi
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Tehran, Shariati avenue, opposite Bahar Shiraz, end of Kaj Street, Army Nursing Faculty
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7750 0201
Email
hengamehabibi@ymail.com
Web page address
http://www.ajaums.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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