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Effect of Community Re-Entry Program (CRP) on disability of Chronic Patients with Schizophrenia

Protocol summary

Study aim
To assess the effect of Community Re-Entry Program (CRP) on disability of Chronic Patients with Schizophrenia
Design
The present study is a quasi-experimental study with pretest-post test design with control group and single blind. Samples were selected using convenience sampling and randomly assigned into two groups of intervention and control.
Settings and conduct
Location: Razi Hospital, University of Iran The method is that after obtaining informed consent, participants will be asked to complete a demographic questionnaire and a World Health Organization Disability Questionnaire before and after the intervention. In order to make a single blind study, the questionnaires will be completed before and after the intervention by a non-researcher and after receiving the necessary training to complete the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Based on the psychiatrist's diagnosis recorded in the case, , No symptoms of acute phase schizophrenia at the time of the interview, More than 5 years have passed since the illness, No symptoms of acute phase schizophrenia at the time of the interview, Don't be an active substance abuser, Do not have severe physical problems and mental retardation, The severity of the disorder is such that it is incapable of performing activities؛ Exclusion criteria: Existence Neurological diseases, orthopedic disorders, blindness and diabetes, Diagnosis of the disorder Bipolar type I and major depression, Mental Illness Following War Injury, Psychosis
Intervention groups
For the intervention group, 16 training sessions (3 sessions per week, 30-90 minutes per week) will be conducted by the instructor (researcher), videotape, and workbook (for patients) in the community; Control group: No training.
Main outcome variables
Disability Of Chronic Patients With Schizophrenia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150615022745N2
Registration date: 2019-10-31, 1398/08/09
Registration timing: retrospective

Last update: 2019-10-31, 1398/08/09
Update count: 0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
ttaghavi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-01, 1397/07/09
Expected recruitment end date
2018-11-10, 1397/08/19
Actual recruitment start date
2018-10-01, 1397/07/09
Actual recruitment end date
2018-11-10, 1397/08/19
Trial completion date
2019-01-10, 1397/10/20
Scientific title
Effect of Community Re-Entry Program (CRP) on disability of Chronic Patients with Schizophrenia
Public title
Effect of Community Re-Entry Program (CRP) in Patients with Schizophrenia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Based on the psychiatrist's diagnosis recorded in the case Age range 18 to 55 years No symptoms of acute phase schizophrenia at the time of the interview More than 5 years have passed since the illness No symptoms of acute phase schizophrenia at the time of the interview Don't be an active substance abuser Do not have severe physical problems and mental retardation The severity of the disorder is such that it is incapable of performing activities Family members (legal guardians) satisfaction with patient participation in research
Exclusion criteria:
Existence Neurological diseases, orthopedic disorders, blindness and diabetes Diagnosis of the disorder Bipolar type I and major depression Mental Illness Following War Injury Psychosis
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into intervention and control groups by block allocation method. The allocation sequence will be generated using the free web site www.randomization.com. To generate the allocation sequence in this system, the number of subjects per block will be set to 4. In addition, the letters A will be assigned to the intervention group and B to the control group, and eventually the allocation sequence will be generated for each block by confirming the production of the allocation sequence in this system. The cards containing the blocks will then be inserted into the standard envelope. Thus, based on the eligible patient, an envelope will be removed by the researcher by accident, and the allocation will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were Chronic Patients with Schizophrenia, who were unaware of the assignment in the study groups
Placebo
Not used
Assignment
Other
Other design features
=

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Nursing Midwifery & Rehabilitation ,Tehran University of Medical Scien
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences. Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.TUMS.FNM.REC.1397.096

Health conditions studied

1

Description of health condition studied
Chronic schizophrenia
ICD-10 code
F20.5
ICD-10 code description
Residual schizophrenia

Primary outcomes

1

Description
Disability rate in chronic schizophrenic patients
Timepoint
Before training and one month after training
Method of measurement
WHODAS 2 36i Disability Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training Community Re-Entry Program in 16 meetings: Meeting 1: Introduction to Community Re-Entry Program: A review of the return to Community Re-Entry Program of familiarity with the program.Meeting 2: Symptoms of Disabling Mental Disorders: The purpose of this meeting is to learn about what drugs are prescribed, and what benefits are obtained with the consumption of drugs.Meeting 3: determined readiness for release: The purpose of this meeting is to learn about the symptoms and behaviors that people must know to prepare for their release.Meeting 4: Planning to Community Re-Entry Program: Patients can be involved in their release schemes by learning about their accommodation and finances.Meeting 5: Communicate with community: The purpose of this meeting is to establish personal communication with the individual in society that can serve as a service source and learn more about the resources and services available in society.Meeting 6: Dealing with stress in society: The purpose of this meeting is to know that stress can play an important role in the disease, and activities that can be used to cope with stress.Meeting 7: Plan a daily schedule: The purpose of this session is to learn the benefits of having a daily schedule and then prepare it.Meeting 8: practice an appointment and do it: The purpose of this session is to learn how to arrange an appointment with the doctor after release.Meeting 9: How drugs prevent recurrence of the disease: The purpose of the meeting is to learn what the reasons for treating the medication are for the cure and the general aims of prescribing drugs and their side effects, such as overweight and how to record a daily record of drug - sleep - sleep - creating, in their calibration sheet.Meeting 10: assessing the impact of prescription drugs: The purpose of the meeting is to learn the use of their grade - ratings checklist and to use these sheets to improve communication with the physician .Meeting 11: Drug - solving problems: The meeting is meant to learn how to recognise the problems caused by medication and to know what measures they should be taking to solve their drug problems, so that the drug should have the best effect.Meeting 12: Solving the Problems Side Effects of Drug Treatment: the meeting is meant to identify possible side effects of drugs and train people to discuss these complications .Meeting 13: identifying and determining warning symptoms for recurrence: The training session aims to teach members about the warning signs of the relapse.Meeting 14: Keeping track of warning Symptoms: The purpose of this meeting is to get people to examine their personal signaling symptoms on a daily basis, and understand that in detecting the symptoms, they need to find a person who can help them identify and examine signs of warning.Meeting 15: Emergency plan formulation: The purpose of the meeting is to teach members of the group to develop an emergency plan.Meeting 16: bring their plan into society: The purpose of the meeting is to enable people to describe their emergency plan and understand how to train all the skills they have learned in the Community Re-Entry Program.
Category
Rehabilitation

2

Description
Control group: In this group, there were no performed intervention, in order to compare the its results with the Experimental group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Psychiatric Care Center(hospital)
Full name of responsible person
Amir Abbas Keshavarz Akhlaghi
Street address
Azadegan highway
City
Tehran
Province
Tehran
Postal code
1398913151
Phone
+98 21 4450 3395
Email
iph@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
researchdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Taraneh Taghavi Larijani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4311
Email
ttaghavi@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheil Eddin Salmani
Position
Research Assistant
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4311
Email
Soheil.e.salmani313@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Soheil Eddin Salmani
Position
Research Assistant
Latest degree
Bachelor
Other areas of specialty/work
Psychiatric Nursing
Street address
Nosrat Ave., Tohid Sq
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6105 4311
Email
Soheil.e.salmani313@gmail.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The documentation is accessible to the research team, and after completion of the study, it could only be made available to the relevant sources with permission of the research team supervisor
When the data will become available and for how long
3 months after publishing the results
To whom data/document is available
Research team's supervisor, School of Nursing and Midwifery Research Deputy
Under which criteria data/document could be used
With the permission of the research team's supervisor
From where data/document is obtainable
Research team's supervisor
What processes are involved for a request to access data/document
Contact with the research team's supervisor
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