Comparison of the Effect of Psychoeducation with Continuous Care Model on Satisfaction of Patients with Schizophrenia and the Patient's caregiver from Mental Health Services Provision
Comparison of the Effect of Psychoeducation with Continuous Care Model on Satisfaction of Patients with Schizophrenia and the Patient's caregiver from Mental Health Services Provision
Design
This clinical trial with control group, three groups, single blind, randomized by blocked method, was performed on 150 patients with schizophrenia (75 people) and their main caregivers (75 people).Thus, each group consisted of 25 patients with schizophrenia and 25 main caregivers.
Settings and conduct
This clinical trial conducted in three groups, including psychoeducation, continuous care model, and control group by single blind at Ibn Sina Psychiatric Hospital in Mashhad. The researcher who performs the study statistics was blind to the study conditions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient's main caregiver should be a first-degree relative and responsible for medical follow-up and patient care at home; Have at least a third-grade education.
Exclusion criteria: main caregiver with mental disorders and taking medication in this area.
Intervention groups
In the psychoeducation group, sessions were designed and conducted for patients based on the content of the psychoeducation program for Patients with Schizophrenia at the Department of Psychiatry, University of Olomoch, Czech Republicsessions. In the main caregiver, psychoeducation sessions were designed and implemented according to Atkinson and Coia (1995) schizophrenic patients' family psychoeducation content.
In the continuous care model group, both patients and main caregivers were trained separately based on Fazlullah Ahmadi's (2001) continuous care model.
The control group received the routine care.
Main outcome variables
Satisfaction of patients with schizophrenia;
Satisfaction of main care patients with schizophrenia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180509039597N2
Registration date:2020-08-14, 1399/05/24
Registration timing:retrospective
Last update:2020-08-14, 1399/05/24
Update count:0
Registration date
2020-08-14, 1399/05/24
Registrant information
Name
Azam Salarhaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 1093
Email address
salarha961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-11, 1398/02/21
Expected recruitment end date
2020-05-10, 1399/02/21
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-06-27, 1399/04/07
Scientific title
Comparison of the Effect of Psychoeducation with Continuous Care Model on Satisfaction of Patients with Schizophrenia and the Patient's caregiver from Mental Health Services Provision
Public title
Comparison of the Effect of Psychoeducation with Continuous Care Model on Satisfaction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire of both the patient and the main caregiver to participate in the study
The patient's main caregiver should be a first-degree relative and responsible for medical follow-up and patient care at home.
Have at least a third-grade education
Exclusion criteria:
Physical, hearing, and visual impairments that interfere with the learning process
The main caregiver of the patient with mental disorders and medication in this area
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed by Permuted block randomization method. Eligible patients were selected by convenience sampling and divided into three groups A, B and C by a researcher who was blind to the study. Then, 13 six- blocks were determined as a combination of groups A, B and C (AABBCC, BBCCAA, CCAABB, BACABC, ACABBC, etc.) and a number between 1 and 13 was assigned to each block. Based on the table of random numbers, the order of entry of blocks into the study and assignment of patients to intervention and control groups was determined. After selecting each patient, her main caregiver was included in the study and was placed in one of the intervention or control groups according to the patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who performs the study statistics be blind to the study conditions.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, both the patient and the main caregiver will be intervened
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh Cinema, University avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
913881394
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.MUMS.REC.1398.036
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20-F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
Satisfaction of patients with schizophrenia
Timepoint
Before the intervention, the time of discharge of the patient from the hospital, one month after the discharge of the patient from the hospital, two months after the discharge of the patient from the hospital
Method of measurement
The Verona Service Satisfaction Scale (VSSS) (2000) in patients
Secondary outcomes
1
Description
Satisfaction of the main caregiver
Timepoint
Before the intervention, the time of discharge of the patient from the hospital, one month after the discharge of the patient from the hospital, two months after the discharge of the patient from the hospital
Method of measurement
the Verona Service Satisfaction Scale (VSSS) (2000) in relatives
Intervention groups
1
Description
Intervention group: both the patient and the main caregiver received psychoeducation. Thus, psychoeducation sessions were designed based on the content of the psychoeducation program for patients with schizophrenia at the department of psychiatry, university of Olomouc, Czech republic. According to this protocol, sessions in groups of 10 people held during 6 sessions of one hour and twice a week as a group discussion when the patient is hospitalized. Also, in the main caregiver, psychoeducation sessions were held during 10 two-hour sessions in groups of 10 people, according to the Atkinson and Coia (1995) schizophrenic patients' family psychoeducation content.
Category
Prevention
2
Description
Intervention group: both the patient and the main caregiver received continuous care model. Patients and main caregivers separately was taught based on Fazlullah Ahmadi's continuous care model (2001) during four stages of identification (one two-hour session), sensitization (6 sessions and each 2-hour session), control (once every two weeks) and evaluation (at each stage) for 12 weeks.
Category
Prevention
3
Description
Control group: they received the routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad, Ibn Sina psychiatric hospital
Full name of responsible person
Dr Fateme Mohareri
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
presidentoffice@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh cinema, Daneshgah avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
8430249051
Phone
+98 51 3841 2081
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
Abbas Heidary
Position
Faculty of Education, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibne-Sina Ave, Doctora Cross, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051-38591511-3
Email
HeidaryA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbas Heidary
Position
Faculty of Education, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibne-Sina Ave, Doctora Cross, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051-38591511-3
Email
HeidaryA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbas Heidary
Position
Faculty of Education, Mashhad University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibne-Sina Ave, Doctora Cross, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051-38591511-3
Email
HeidaryA@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
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
Title and more details about the data/document
Information on the main outcome is available for sharing
When the data will become available and for how long
One year after printing results
To whom data/document is available
My data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
Data will be available with permission from Mashhad University of Medical Sciences
From where data/document is obtainable
Vice chancellor for research, Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
You must apply for a deputy of Mashhad University of Medical Sciences