Protocol summary

Study aim
Determining the effect of BASNEF model on adherence to medication in patients undergoing coronary artery by pass graft surgery at chamran hospital
Design
The clinical trials are two group and three - step . in two groups of test and control.The study groups of this study include 72 patients Random assignment who are undergoing coronary artery bypass graft surgery
Settings and conduct
this study consists of 72 patients undergoing coronary artery bypass.it is possible that the conditions of entering the study and have completed the consent form .the selected patients (72 patients)will be divided into two groups of 36 individuals.Then, the BASNEF questionnaires will be given to patients, before coronary artery bypass graft surgery and will be completed by them.After that,According to the information that obtained from the BASNEF questionnaire the content of the training sessions will be set for the patients after surgery.Four training sessions in perioud of 40 - 60 minutes will be held within a month at the Shahid hospital's health training unit.The classes will be used in training, educational literature and video clips and educational pictures after that, they are asked to express their opinions and experiences regarding the process of care.
Participants/Inclusion and exclusion criteria
Entry criteria:patients who are undergoing coronary artery by pass graft surgery. Not Entry criteria :Patients who do not have the physical ability to participate in training sessions.
Intervention groups
Test group : Examination of the effect of the BASNEF model on adherence to medication after coronary artery bypass. control group : adherence to medication, based on hospital discharge education in patients, after coronary artery bypass graft surgery.
Main outcome variables
Mean score of adherence items to medication , mean of overall adherence to medication

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180729040629N1
Registration date: 2018-10-24, 1397/08/02
Registration timing: registered_while_recruiting

Last update: 2018-10-24, 1397/08/02
Update count: 0
Registration date
2018-10-24, 1397/08/02
Registrant information
Name
Atefeh Torknejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3264 3526
Email address
torknejad@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of BASNEF Model on adherence medication in patients undergoing coronary artery bypass graft surgery
Public title
''Effect of BASNEF Model on adherence medication in patients undergoing coronary artery bypass graft surgery''
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are undergoing coronary artery bypass graft surgery Patients who are interested in participating in the study Patients who talks in Persian. Patients who Have not been involved in educational sessions (any other research in the context of the relevant study) Patients who have no pshycologic problems A member of his family will be able to participate in educational sessions
Exclusion criteria:
Patients who do not live in Isfahan County. Patients who are physically unable to participate in training sessions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method In this case, the number of 36 cards with number one and 36 cards will be sealed with the number two in an envelope. On the day of the random division of the research units, they will be asked to choose a card. The individuals with the number one belong to the test group. and people in number two will be in control group
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences.,Hezarjereeb Avenue
City
Isfahan
Province
Isfehan
Postal code
73461_81746
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.055

Health conditions studied

1

Description of health condition studied
patients undergoing coronary artery bypass graft surgery
ICD-10 code
I25.118
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris

Primary outcomes

1

Description
total score of adherence to medication in patients, after Coronary Artery Bypass Graft Surgery
Timepoint
Examination of the total score of adherence to medication, prior the intervention, immediately and 60 days after the educational intervention
Method of measurement
Modanlo questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
holding 4 training sessions, after discharge, baced on the BASNEF model , for patients who undergiong coronary artery bypass graft surgery. in these sessions will be used, video , booklet and brochure . the content of sessions will be formulated based on the information obtained from the BASNEF questionnaires, and that is about post surgery care, for patients after coronary artery bypass surgery .if they have any question , patients can also contact the researcher during meetings . and a member of the patient's family will be present in the meetings .
Category
N/A

2

Description
Control group: The control group will receive nurses education while discharging from hospital and they will also recevie Educational booklet. the Modanlo questionnaire will also complete by them, and will be asked to complete the questionnaire, three months after their discharge. Therefore, no training sessions will be held for the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Atefeh Torknejad
Street address
Shahid Chamran Hopital, Salman-e-Farsi St, Moshtagh St,
City
Isfahan
Province
Isfehan
Postal code
81465-1148
Phone
+98 31 3611 5313
Email
crc@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayagh haghjoo javanmard
Street address
Isfahan University of Medical Sciences., Hezarjereeb Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Torknejad
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96/4, Dead End. 24., Abolhasn Isfahani Avenue., Moshtagh St.
City
Isfahan
Province
Isfehan
Postal code
8153959744
Phone
+98 31 3264 3526
Email
torknejad@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Babaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery., Isfahan University of Medical Sciences., Hezarjereeb Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7541
Email
Babaee@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Torknejad
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96/4., Dead End. 24., Abolhasan Isfahani Avenue., Moshtagh St
City
Isfahan
Province
Isfehan
Postal code
81539-59744
Phone
+98 31 3264 3526
Email
torknejad@nm.mui.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
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