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Survey of efficacy and effectiveness of after discharge services and severe and chronic patients phone call follow up performed by the nursing staff

Protocol summary

Summary
the objective of this study is to compare the clinical outcomes and cost-effectiveness of model of case-manager services (home-visit) for serious mentally ill patients by nurses.The target population is the individuals with schizophrenia and bipolar mood disorders spectrum living in Tehran.180 participants will be selected from mental hospitals or wards after discharge or from outpatients services and randomly located into three groups.In the first group, the intervention will be carried out by nurses by providing 12-month consequences home-visit. In each visit, the patients will be supervised for their medication prescribed by the patient's psychiatrist,the patient and caregivers are trained, the symptoms of disease and the side effects of drugs are reported to the patient's psychiatrist.In the second group by having a phone call, patient have been recalled for their next visit in the clinic.In the third group no intervention will be provided.The instruments of YMRS, FEIS,PANSS,caregiver's knowledge questionnaire, KELS, quality of life questionnaire, SF-36, CSQ-8, GHQ, cost questionnaire will be used to measure clinical outcomes and cost-effectiveness of the interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110261959N5
Registration date: 2012-01-19, 1390/10/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-01-19, 1390/10/29
Registrant information
Name
Seyed Kazem Malakouti
Name of organization / entity
Iran University of Medical Science - Tehran Psychiatric Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 0200
Email address
malakouti.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
mental health research center of Tehran(Pardise Hemat) university of medical siences, Shahid Behehti university of medical siences, Tehran(Pardise Hemat) university of medical siences
Expected recruitment start date
2007-12-01, 1386/09/10
Expected recruitment end date
2009-03-01, 1387/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of efficacy and effectiveness of after discharge services and severe and chronic patients phone call follow up performed by the nursing staff
Public title
Treatment follow up of severe and chronic Mentally ill patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:presence of schizophrenia or bipolar spectrum disorders,age 15-60 years old,having at least one hospitalization history for exacerbation in her/his past history,need for aftercare services according to her/his psychiatric due to low level of compliance Exclusion criteria: having organic brain disorder,having cuncurrently substance use disorders, using similar services from other sources
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rechearch Cernter of Shahid Beheshti University of Medical Sience
Street address
near of Taleghani Hospital, Evin, Chamran
City
Tehran
Postal code
Approval date
2008-06-15, 1387/03/26
Ethics committee reference number
54/26/3/87

Health conditions studied

1

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

2

Description of health condition studied
schizoaffective disorder
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders

3

Description of health condition studied
bipolar affective disorders
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorders

Primary outcomes

1

Description
relapse and rehospitalization due to exacerbation of disorder
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
observing the course of disease

2

Description
caregiver's knowledge
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
caregiver's knowledge questionnaire

3

Description
caregiver's burden
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
family burden interview scale

4

Description
health of caregiver
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
general health questionnaire

5

Description
patient's satisfaction from services
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
client satisfaction questinnaire-8

6

Description
patient's quality of life
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
guality of life questionnaire-36

7

Description
cost of treatment,cost-effective of evaluation
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
cost questionnaire

8

Description
life skills of patients
Timepoint
at the biginning and after 12 months of inervention
Method of measurement
KELZ life skill scale

9

Description
severity of psychopathology
Timepoint
before and after one year of intervention
Method of measurement
Young Mania Rating Scale(YMRS), Positive and Negetive Syndrome Scale(PANSS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention groups,calling case managers,include nurses and phone following.The participants recieve home-visit by a case-manager monthly for 12 consecutive months.The first group include nurses.They supervise the patient's drug treatment according to the patient's psychiatrist prescription,train the patient and her/his caregivers according to 12-month topics, report the patients mental status/drug side effects to the psychiatrist.In the second group, by having a phone call, patient have been recalled for their next visit in the clinic.The control group is the third group that receives the treatment facilities which are available "as usual services" from society.they are contacted by telephone each 3-month to complete the cost questionnaire.
Category
Prevention

2

Description
In the control group no intervention will be provided.They are contacted by telephone each 3-month to complete the cost questionnaire and asking probability of addmition at 3-month ago.The patients receives the treatment facilities which are available"as usual services" from society.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital,inpatient and outpatient services
Full name of responsible person
Seyed Kazem Malakouti
Street address
Niayesh St. Sattarkhan Ave. Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Iran Hospital
Full name of responsible person
Safiye Amin
Street address
Niayesh St. Sattarkhan Ave. Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Arash Mirabzadeh
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mental Health Research Center
Full name of responsible person
Mehdi Nasr Esfahani
Street address
Mansuri st. Niayesh st. Sattarkhan ave. Tehran Psychiatric Institude
City
Tehran
Grant name
Grant code / Reference number
5773/پ/26/26
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mental Health Research Center
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sience
Full name of responsible person
Alireza Zahiroddin
Street address
near of Taleghani Hospital, Evin, Chamran
City
Tehran
Grant name
Grant code / Reference number
ر-ع-3/877
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sience
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Tehran(Pardise Hemat) University of Medical Sience
Full name of responsible person
Dr.Abolfazl Khosravi
Street address
Between Sheikh Fazlollah and Chamran, Shahid Hemat
City
Tehran
Grant name
Grant code / Reference number
م/ت/ 161
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran(Pardise Hemat) University of Medical Sience
Proportion provided by this source
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 sience-Tehran psychiatric Institude
Full name of responsible person
Dr.Seyed Kazem Malakouti
Position
Fellow,Geriatric psychiatry
Other areas of specialty/work
Street address
Shahid Mansuri St. Niayesh St. Sattarkhan Ave. Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 66550200
Email
sk-malakouti@tums.ac.ir
Web page address
www.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical siences-Tehran psychiatric Institude
Full name of responsible person
Dr.Seyed Kazem Malakouti
Position
Fellow,Geriatric Psychiatry
Other areas of specialty/work
Street address
Shahid Mansuri St. Niayesh St. Sattarkhan Ave. Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 21 6655 0200
Email
sk-malakouti@tums.ac.ir
Web page address
www.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran university of medical siences,Tehran Psychiatric Institude
Full name of responsible person
Dr.Seyed Kazem Malakouti
Position
Fellow,Geriatric psychiatry
Other areas of specialty/work
Street address
Shahid Mansuri St. Niayesh St. Sattarkhan Ave. Tehran
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 0200
Fax
+98 21 6655 0200
Email
sk-malakouti@tums.ac.ir
Web page address
www.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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