Protocol summary

Summary
This study is designed to determine the effect of pharmaceutical therapy education on knowledge, attitude and admission in patients with psychological problems admitted to Farshchian Hospital of Hamedan. In this study, mental patients will be selected by available sampling method and will be classified into two groups of control and test by random block method. The sample size will be 78 people. Sampling will be continued for at least one month. According to the physician's diagnosis and patients’ records, lack of mental retardation, not being in acute conditions of psychosis and hospitalization even for one time, will be considered as inclusion criteria. In each stage of study, if the selected patient being reluctant to continue the study, he or she will be excluded. A researcher who attends psychiatric wards in the evening shift after the completion of visiting, by available sampling method will be selected patients with mental disorders who meet the criteria for research. Then, the consent for taking part in the study will be taken from patients and the process of training will be explained to the patients. Demographic information questionnaire, attitude toward medicine, and pharmaceutical questionnaire will be completed when patient's visiting time is over and we will be not require a specific procedure. The medicine admission checklist which is at 6 p.m. and it’s time for the patients to take medication, will be completed by researcher without patients knowing that. Groups will be divided to control and test groups by random blocking method. This method will be use to ensure that sample members with the same number and in consecutive time intervals enter into the study. After implementing 4 training sessions for the intervention group, which lasts for one month, and immediately after the completion of these sessions, attitude toward medicine and pharmaceutical knowledge questionnaire will be completed again for intervention group. The medicine admission checklist which is at 6 p.m. and it’s time for the patients to take medication, will be completed by researcher without patients knowing that. No intervention will be applied for control group. Questionnaires for the control group will be completed at the beginning and end of the sessions. The primary outcome of study will be knowledge and attitude toward medication, and secondary outcome of study will be medication admission variable

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017071033378N4
Registration date: 2017-10-19, 1396/07/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of medication education on knowledge, attitude and accepting psychiatric patients in Farshchian educational and medical center of Hamedan
Public title
Effect of medication education on knowledge, attitude and accepting psychiatric patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: According to the physician's diagnosis and patient's records, lack of mental retardation; not being in acute conditions of psychosis; literacy; ability to sit in the chair for a maximum of 60 minutes; verbal communication ability; being older than 18 years old; at least one hospitalization record due to the recurrence of disease; mental disorder shouldn’t be due to substance abuse and psychotropic drugs. Exclusion criteria: in each stage patient reluctance to continue the study; existence of patient in acute conditions of psychosis; patients who will be discharged before the completion of study by the physician permission or with personal consent; patients who think about suicide during the study; absence of patient in one of the training sessions.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
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 Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Postal code
Approval date
2017-07-10, 1396/04/19
Ethics committee reference number
IR.UMSHA.REC.1396.313

Health conditions studied

1

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

2

Description of health condition studied
Psychosis
ICD-10 code
ّF21
ICD-10 code description
Schizotypal Disorder

3

Description of health condition studied
Psychosis
ICD-10 code
F25
ICD-10 code description
Schizoaffective Disorder

4

Description of health condition studied
Psychosis
ICD-10 code
F31
ICD-10 code description
Bipolar Affective disorder

5

Description of health condition studied
Psychosis
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Knowledge
Timepoint
Before intervention, immediately after the intervention
Method of measurement
Knowing About Medication Questionnaire (KAM)

2

Description
Attitude
Timepoint
Before intervention, immediately after the intervention
Method of measurement
Drug Attitude Questionnaire

Secondary outcomes

1

Description
Accepting Medication
Timepoint
Before intervention, immediately after the intervention
Method of measurement
Accepting Medication Check List

Intervention groups

1

Description
For the first intervention group, the intervention will be conducted in pharmaceutical therapeutic training session format by the researcher in the form of lecture (audiovisual), and question and answer. Four training sessions for each group will be held twice a week for 45 to 60 minutes (30 minutes of training, 5 minutes for review and 15 minutes for questions and answers) in one of the training rooms of psychiatric wards. Trainings will be conducted for 4 groups of 10 participants in each group. Selection of 4 groups of 10 people will be based on articles and review of the texts. The time of meeting will be set so that all the participants will be satisfied and visiting time or nursing procedures time will be avoided.
Category
Other

2

Description
Control group just recieve routin cares
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Mina Nezafatdoost
Street address
Mirzadeh Eshghi street, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Vice chancellor Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Research and Technology Vice chancellor Hamedan University of Medical Sciences, Shahid Fahmideh street, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice chancellor Hamedan 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
Hamedan University of Medical Science
Full name of responsible person
Mina Nezafatdoost
Position
Student of MS/Nurse
Other areas of specialty/work
Street address
Hamedan, Shahid Fahmideh street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
65178-38698
Phone
+98 81 3838 0320
Fax
+98 81 3838 0447
Email
m.nezafatdoost@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Efat Sadeghian
Position
PHD of Nursing
Other areas of specialty/work
Street address
Hamedan, Shahid Fahmideh street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
65178-38698
Phone
+98 81 3838 0320
Fax
+98 81 3838 0535
Email
Sadeghianefat@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Mina nezafatdoost
Position
Student of MS/Nurse
Other areas of specialty/work
Street address
Hamedan, Shahid Fahmideh street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
65178-38698
Phone
+98 81 3838 0320
Fax
+98 81 3838 0447
Email
m.nezafatdoost@gmail.com
Web page address

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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