Protocol summary

Study aim
Investigating the Impact of Community Reintegration Program (CRP) on Medication Adherence and Readmission Rates of Psychiatric Patients
Design
Clinical trial with control group, non-randomized, on 78 patients
Settings and conduct
The study will be conducted in Sina and Golestan hospitals of Ahvaz on 78 patients randomly and in two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent to participate in the study; age of diagnosis between 20 and 50 years; living with family; not having a personality disorder; literate in reading and writing; at least one year has passed since contracting the disease Exclusion criteria: Aggression and the possibility of harming other members of the group
Intervention groups
Intervention group: patients with mental disorders hospitalized in the psychiatric departments of Golestan Ahvaz Hospital،In addition to the usual treatments, the intervention group receives the community return program (CRP). The research program will be conducted in a special room for group therapy of patients, which was equipped with audio and video devices and suitable tables and chairs for patients Control group: patients with mental disorders hospitalized in the psychiatric departments of Sina Ahvaz Hospital،The control group is chosen as the comparison group and no intervention is done in it. The members of the control group received treatment and usual care.
Main outcome variables
The impact of the community return program, readmission, drug compliance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231210060326N1
Registration date: 2024-01-28, 1402/11/08
Registration timing: registered_while_recruiting

Last update: 2024-01-28, 1402/11/08
Update count: 0
Registration date
2024-01-28, 1402/11/08
Registrant information
Name
mojtaba norozi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 921 035 3323
Email address
norozi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Community Reintegration Program (CRP) on Medication Adherence and Readmission Rates of Psychiatric Inpatients in the Mental Health Ward of Golestan Hospital, Ahvaz
Public title
Effect of Community Reintegration Program (CRP)on Medical adherence and readmission rates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Age between 20 and 50 years Living with family Not having a personality disorder At least one year has passed since the infection
Exclusion criteria:
Those who can not read and write
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics comittee of Ahvaz university of Medical Sciences
Street address
No32, Eqbal Ave, Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۴۴۴۸۴
Approval date
2023-12-21, 1402/09/30
Ethics committee reference number
IR.AJUMS.REC.1402.448

Health conditions studied

1

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

Primary outcomes

1

Description
Medication adherence score in Madanlo questionnaire
Timepoint
Before the intervention, 4 months after the intervention
Method of measurement
Modanloo medication compliance questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This program consists of 16 1-hour sessions, which will be held twice a week. Sessions 1 to 8 are for patients who are preparing to be discharged from the hospital or care centers, and sessions 9 to 16 will be held in the hospital, outside the hospital, mental health centers, or at the patient's residence.The intervention will consist of a package that will include a community reentry program to educate people with debilitating mental disorders, which in terms of content will include symptoms and behaviors before discharge from the hospital or to achieve independent living, planning for discharge, or transfer to Living situations, communication with social service providers, understanding the benefits of taking medications, medication issues and problems, and reducing the likelihood of relapse. The components of the community return program include instructor manuals, videotapes, and workbooks (specific to participants). The method of conducting the intervention will be that the trainer explains the objectives of each session and explains the terms and encourages the participants to learn. In the part of the video presentation, the pioneers play the role of patients and show them the necessary educational skills and concepts, and the trainers will stop the video appropriately and ask the questions of the client in the trainer's manual, so as to attract the attention of the participants and Evaluation of the understanding of the content should be done in each session​. After the sessions , one and three months after discharge, patients complete the medication compliance questionnaire. Control group:The control group is chosen as the comparison group and no intervention is done in it.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Psychiatry, Golestan and Sina Hospital, Ahvaz
Full name of responsible person
Mojtaba Norozi
Street address
No. 32, Golestan Boulevard, Iqbal Street
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۴۴۴۸۴
Phone
+98 61 3338 3208
Email
mojtabanorozi20@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Golestan Boulevard, University of Medical Sciences, Research Unit
City
Ahvaz
Province
Khouzestan
Postal code
15794 – 61357
Phone
+98 61 3311 3815
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Norozi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No32,Zartosht Ave,Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۴۴۴۸۴
Phone
+98 61 3338 3417
Email
mojtabanorozi20@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Norozi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No32,Zartosht Ave,Golestan blvd
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۴۴۴۸۴
Phone
+98 61 3338 3417
Email
Mojtabanorozi20@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Norozi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Eqbal ave_Golestan Blvd_Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۶۹۴۴۴۸۴
Phone
+98 921 035 3323
Fax
Email
norozi.M@ajums.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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