The results of this study can make a pattern for other clinical pharmacists for working in a psychiatry hospital
Design
Two arm parallel groups including intervention group and control group each consists of 56 patients, without blinding, randomized with Random Permuted Block method
Settings and conduct
The impact of clinical pharmacist interventions on the clinical outcome of patients with Bipolar Disorder (BD) who admitted in Roozbeh hospital will be evaluated during hospital stay , one month and three months after discharge
Participants/Inclusion and exclusion criteria
Patients diagnosed with Bipolar Disorder type 1 based on DSM 5 criteria;
Patients older than 18 years of age;
Taking at least one antipsychotic or mood stabilizer
Intervention groups
In intervention group, clinical pharmacist interventions and consultations during hospitalization, one month and three months after discharge are conducted and the questionnaires will be filled. In control group, no clinical pharmacist intervention is conducted except for life threatening errors and the questionnaires will be filled during hospitalization, one month and three months after discharge. All patients in this study (including intervention and control groups) will benefit from routine and standard pharmacotherpy program according to the orders of their specialists
Main outcome variables
Medication Appropriateness Index;
Depression score;
Quality of life;
Medication adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210307050613N1
Registration date:2021-08-21, 1400/05/30
Registration timing:registered_while_recruiting
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
nazanin gorgzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4436 3885
Email address
nazanin.gz67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-20, 1400/05/29
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of clinical pharmacist interventions on the clinical outcome of patients with Bipolar Disorder (BD) in Roozbeh hospital
Public title
Impact of clinical pharmacist interventions on the clinical outcome of patients with Bipolar Disorder (BD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with Bipolar Disorder type 1 based on DSM 5 criteria
Patients older than 18
Taking at least one antipsychotic or mood stabilizer
Exclusion criteria:
Psychiatric comorbidities including Schizophrenia, Obsessive-Compulsive Disorder,Generalized anxiety Disorder, Panic Disorder
Drug or disease induced bipolar disorder
Substance abuse (other than nicotin or caffeine) since one year ago
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
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
Ethics Committee of the Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
No 16, Jahad Alley., South Shahran St
City
Tehran
Province
Tehran
Postal code
1474948185
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.TUMS.TIPS.REC.1400.029
Health conditions studied
1
Description of health condition studied
Bipolar Disorder type 1
ICD-10 code
F31
ICD-10 code description
Bipolar Disorder
Primary outcomes
1
Description
Medication Appropriateness Index
Timepoint
During hospitalization, one month and three months after discharge
Method of measurement
Medication Appropriateness Index questionnaire
Secondary outcomes
1
Description
Depression score
Timepoint
During hospitalization, one months and three months after discharge
Method of measurement
Beck Depression Inventory questionnaire
2
Description
WHOQOL-BREF (WHO Quality Of Life)
Timepoint
During hospitalization, one month and three months after discharge
Method of measurement
WHO Quality Of Life questionnaire
3
Description
Adherence to treatment plan
Timepoint
During hospital stay, one month and three months after discharge
Method of measurement
Medication Adherence Rating Scale
Intervention groups
1
Description
Intervention group: clinical pharmacist interventions and consultations during hospitalization then one month and three months after discharge as an outpatient
Category
Treatment - Other
2
Description
Control group: clinical pharmacist interventions and consultations only in life-threatening cases during hospitalization then one month and three months after discharge as an outpatient
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Nazanin Gorgzadeh
Street address
South Kargar
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Fax
+98 21 5541 2756
Email
hosp_roozbeh@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Gorgzadeh
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 4436 3885
Email
pharmacy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Gorgzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
South Shahran
City
Tehran
Province
Tehran
Postal code
1474948185
Phone
+98 21 4436 3885
Email
nazanin.gz67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Gorgzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
South Shahran
City
Tehran
Province
Tehran
Postal code
1474948185
Phone
+98 21 4436 3885
Email
nazanin.gz67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nazanin Gorgzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
South Shahran
City
Tehran
Province
Tehran
Postal code
1474948185
Phone
+98 21 4436 3885
Email
nazanin.gz67@gmail.com
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