Effectiveness of “Iranian Modified Community Reentry module (CRM)” on relapse prevention, medication compliance and quality of life in patients with schizophrenia
Aim: to assess the effectiveness of Iranian modified version of community re- entry program (CRM) on relapse prevention, improvident of quality of life and treatment compliance in patient with schizophrenia. Study plan: The study will be performed on inpatient schizophrenia patients in Iran Psychiatric Hospital, from February, 2012 to January, 2013. This is a randomized controlled clinical trial. Patients will be divided into two equal groups with 50 persons. Interventions: All patients will be treated using standard chemotherapeutic agents. They may use depot anti psychotic medications, however this will be considered as confounding factor. We use the following questionnaires: PANSS and quality of life questionnaire. Patients will be visited regularly during the first month of hospitalization in Iran Psychiatric Hospital. CRM group will be educated according to reference book and training movie. We evaluate patients at months 0, 3, 6 and 12. Primary outcomes: Relapse prevention, improvement of quality of life and treatment compliance in patient with schizophrenia.
General information
Acronym
CRM Project
IRCT registration information
IRCT registration number:IRCT201106226860N1
Registration date:2012-02-27, 1390/12/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Amir Hosein Jalali nadoushan
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 5615
Email address
ahjalali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of “Iranian Modified Community Reentry module (CRM)” on relapse prevention, medication compliance and quality of life in patients with schizophrenia
Public title
Effectiveness of Iranian modified version of CRP in schizophrenia relapse prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia, based on DSM-IV-TR criteria; 2. Hospitalization; 3. informed consent; 4. age: 18-65 yr; 5. living with at least one closed family member after discharge; 6. no employment after discharge; 7. living in Tehran or Alborz provinces; 8. Availability; 9.Consent of attending physician; Exclusion criteria: 1. Changing Location; 2. No Consent to enter the study; 3. Failure to participate in more than two thirds of the meetings.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-12-14, 1390/09/23
Ethics committee reference number
90-03-121-15354-39704
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Medication compliance
Timepoint
months 0, 3, 6, 12
Method of measurement
questionnaires
2
Description
Quality of life
Timepoint
months 0, 3, 6, 12
Method of measurement
questionnaires
3
Description
Relapse prevention
Timepoint
months 0, 3, 6, 12
Method of measurement
questionnaires
Secondary outcomes
1
Description
relapse
Timepoint
month 12
Method of measurement
clinical interview and/or hospitalization
Intervention groups
1
Description
CRM (Community Reentry Module), A Program to increase awareness of patients about the disease and drug treatment. Besides increasing awareness of patients. They will also learn social skills.
Category
Rehabilitation
2
Description
Psycho education & group occupational therapy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
F. Golband
Street address
Keshavarz Blvd
City
Tehran
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Jalali Nodushan
Position
Psychiatrist / Assistant Prof
Other areas of specialty/work
Street address
Tehran Psychiatric Institute, Sattarkhan St
City
Tehran
Postal code
Phone
+98 21 6650 6862
Fax
Email
ahjalali@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Jalali Nodushan
Position
MD, Psychiatrist
Other areas of specialty/work
Street address
Tehran Psychiatric Institute
City
Tehran
Postal code
Phone
+98 21 6650 6862
Fax
Email
ahjalali@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)