Determine the effect of home visit on patient self-efficacy and family psychological burden of schizophrenia patients
Design
This study was a randomized clinical trial with two groups (intervention and control), pre and post-test design, and not-blinded.
Settings and conduct
This study was conducted on 60 schizophrenia patients who referred to Ebne- Sina hospital of Mashhad that were randomly divided into two groups (n = 30).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of mental retardation.
Exclusion criteria: Not attending in the post test.
Intervention groups
Intervention group: in intervention group, was conducted home visitation according to community mental health team management for 2 months (6 sessions of 45 to 60 minutes) for patients.
Control group: in control group, was conducted routine education (with educational pamphlet) for 2 months, too.
Main outcome variables
Patient Self-Efficacy
Family Psychological Burden
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038353N1
Registration date:2018-04-24, 1397/02/04
Registration timing:retrospective
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Javad Abootoraby
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
abootorabybj1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-01-05, 1396/10/15
Actual recruitment start date
2017-11-06, 1396/08/15
Actual recruitment end date
2018-01-05, 1396/10/15
Trial completion date
empty
Scientific title
The Effect of Home Visitation on Patient Self-Efficacy and Family Psychological Burden of Schizophrenia Patients
Public title
The Effect of Home Visitation on Patient Self-Efficacy and Family Psychological Burden of Schizophrenia Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having schizophrenia according to DSM-5.
The family members of the patient are caring for him.
Exclusion criteria:
Experience emotional crisis such as divorce and death of loved ones.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patient divided to intervention and control group with simple randomization method (with lottery).
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567899
Approval date
2017-11-01, 1396/08/10
Ethics committee reference number
IR.MUMS.REC.1396.277
Health conditions studied
1
Description of health condition studied
Self-Efficacy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Psychological Burden
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-Efficacy
Timepoint
Before the intervention and the end of second month
Method of measurement
Chronic Disease Self-Efficacy Scale
2
Description
Psychological Burden
Timepoint
Before the intervention and the end of second month
Method of measurement
Zarit Burden Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in intervention group, was conducted the home visit program according to community mental health team management for 2 months (6 sessions of 45 to 60 minutes) for patients. This program includes providing pharmaceutical and non-pharmaceutical services, providing services group and by psychiatrist, community psychiatrist, social worker, occupational therapist and psychologist, and in some cases general practitioner.
Category
Prevention
2
Description
Control group: in control group, was conducted routine education (with educational pamphlet) for 2 months, too.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn-e Sina Hospital
Full name of responsible person
Fateme Mohareri
Street address
Next Astan Ghods Naghlie, end of Hor Ameli St, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567891
Phone
+98 51 3530 0001
Email
MohareriF1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
1213445555
Phone
+98 51 3223 1061
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Javad Abootorabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567891
Phone
+98 51 3859 1511
Email
AbootorabyBJ1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567891
Phone
+98 51 3859 1511
Email
VagheeS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Abootorabi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567891
Phone
+98 51 3859 1511
Email
AbootorabyBJ1@mums.ac.ir
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The study report published in the dissertation form and article for researcher.
When the data will become available and for how long
The start of access is 6 months after the announcement of the results.
To whom data/document is available
Researchers at university centers
Under which criteria data/document could be used
Data is authorized only with permission from the author of the articles and with the source.
From where data/document is obtainable
Javad Abootorabi, School of Nursing and Midwifery, Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads, Contact Number: 00989151579378, E-Mail: AbootorabyBJ1@mums.ac.ir
What processes are involved for a request to access data/document
After submitting a request, the request is reviewed and, if the request is accepted, is answered within 1 month.