Improving mental health of type 1 bipolar patients and their support after discharge
Design
Samples will be randomly divided into intervention and control groups. the sample selection sequences will be determined by the project statistical consultant using random allocation software consisting of 15 hex blocks, which will be placed in each block of three sample groups. Envelopes are numbered from one to 90 (sample size) in order to cover the process of random assignment of group names.
Settings and conduct
We have two intervention and control groups. the demographic and Yang questionnaires were filled out by patients after discharge and then performed for three months and then at the end of three months again the patients completed the Yang questionnaire to assess the severity of symptoms. month is considered as both groups fill in the questionnaire monthly without intervention. the study will be conducted at 22 Bahman psychiatric hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study are patient and family informed consent and bipolar definitive diagnosis of type 1 (mood disorder phase 1) and having at least 18 years of age and mental disability. discard the research and also complete the questionnaire if it is incomplete.
Intervention groups
Includes nursing care aimed at promoting the mental health of the patient, accessing basic mental health care, evaluating the patient's mental health, family support and education, and patient support and education.
Main outcome variables
Rapid return to pre-disease performance and patient return to society and prevention of recurrence of a faulty cycle of recurrence and readmission and reduction of hospital bed occupation and imposing high treatment costs for the family and treatment system
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190928044911N1
Registration date:2020-02-01, 1398/11/12
Registration timing:retrospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Arghvan Raeisolhagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 2524
Email address
a.raeisolhagh@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hospital base nursing home care on severity of symptoms in bipolar 1discharghed patients at 22 bahman hospital in qazvin in1398
Public title
Effect of hospital base nursing home care on severity of symptoms in bipolar 1discharghed patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' inclusion criteria for this study: patient and family informed consent
Bipolar type I definite diagnosis (mood disorder phase 1)
Having at least 18 years of age
Mental disability
Exclusion criteria:
The exclusion criteria can also be withdrawn completely at any time when the patient or his / her family refuses to participate in the study
The questionnaire will be excluded if is incomplete.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly divided into intervention and control groups. The sample selection sequences will be determined by the project statistical consultant using random allocation software consisting of 15 hex blocks which will be placed in each block of three sample groups.In order to cover the process of random assignment of the names of groups placed in envelopes, these envelopes are numbered from one to 90 and arranged in a box, respectively, by the researcher making sampling during the envelope content. However, the envelope content represents the study groups, and the samples will be selected from the first envelope in order of number after entering the study and, depending on the envelope content, will fall into one of the study groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee on Ethics in Biomedical Research of Qazvin University of Medical Sciences
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2019-11-21, 1398/08/30
Ethics committee reference number
IR.QUMS.REC.1398.192
Health conditions studied
1
Description of health condition studied
Bipolar type 1( manic phase )
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Severity of symptoms in bipolar 1
Timepoint
Evaluation of severity of symptoms before and after intervention for 3 months and then for monthly follow-up for 6 months.
Method of measurement
Yang questionnaire
Secondary outcomes
1
Description
Severity of symptoms in bipolar 1
Timepoint
Evaluation of severity of symptoms before and after intervention for 3 months and then for monthly follow-up for 6 months.
Method of measurement
Yang questionnaire
Intervention groups
1
Description
Intervention group: for three months (home nursing care) includes promotion of patient mental health, access to basic mental health care, evaluation of patient mental health, family support and education, and patient support and education. telephone calls are made every 15 days and patient and family appointments are made monthly.
Category
Rehabilitation
2
Description
Control group: In the control group, no interventions are performed by the investigator. Patients receive their routine treatments.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvinu niversity of medical sciences, 22 bBahman Psychiatric Hospital
Full name of responsible person
Arghavan Raeisolhagh
Street address
Second floor، Block 8 ، Farabi of 54 unit، Rahmat alley، Salman Farsi Street، Valfajr St، Kosar town
City
Qazvin
Province
Qazvin
Postal code
3471945473
Phone
+98 28 3377 2524
Fax
Email
a.raesolhagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Manochehr Mahram
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3337 5518
Fax
+98 28 3337 5518
Email
chancellor@qums.ac.ir
Web page address
http://qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Arghvan Raeisolhagh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor، Block 8 ، Farabi of 54 unit، Rahmat alley، Salman Farsi Street، Valfajr St، Kosar town
City
Qazvin
Province
Qazvin
Postal code
3471945473
Phone
+98 28 3377 2524
Fax
Email
a.raeisolhagh@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Arghvan Raeisolhagh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor، Block 8 ، Farabi of 54 unit، Rahmat alley، Salman Farsi Street، Valfajr St، Kosar town
City
Qazvin
Province
Qazvin
Postal code
3471945473
Phone
+98 28 3377 2524
Fax
Email
a.raeisolhagh@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Arghvan Raeisolhagh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Second floor، Block 8 ، Farabi of 54 unit، Rahmat alley، Salman Farsi Street، Valfajr St، Kosar town
City
Qazvin
Province
Qazvin
Postal code
3471945473
Phone
+98 28 3377 2524
Fax
Email
a.raeisolhagh@qums.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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available