Protocol summary

Study aim
Comparison the Effect of Education by Teach Back Method and Group Education on Self-efficacy of Patients with Myocardial Infarction
Design
Clinical trial with one control and two intervention groups with parallel groups, no blinding, on 108 patients, statistical software was used for randomization.
Settings and conduct
The study site was the CCU ward of Shahid Rajaei Cardiovascular Hospital in Tehran. There was no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having reading and writing ability; Myocardial infarction for the first time. Non-inclusion criteria: Having a history of mental illness; being educated in any medical major
Intervention groups
Intervention group 1(TeachBack training group): Individual feedback-based training on myocardial infarction, medications, diet, activity and symptoms. Intervention group 2: Group training three-member groups about myocardial infarction, medications, diet, activity and symptoms. Control group: will receive routine training.
Main outcome variables
Self-efficacy score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210410050920N1
Registration date: 2021-07-03, 1400/04/12
Registration timing: retrospective

Last update: 2021-07-03, 1400/04/12
Update count: 0
Registration date
2021-07-03, 1400/04/12
Registrant information
Name
maryam rezaei
Name of organization / entity
Rajaee cardio and vascular center
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 5188
Email address
rezaeinurse.maryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Teach Back training and group training on self-efficacy among myocardial infarction patients
Public title
The effect of feedback-based training and group training on self-sufficiency of myocardial infarction patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Myocardial infarction for the first time Having reading and writing ability
Exclusion criteria:
Having a history of mental illness Being educated in any medical major
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with block of size six, individual randomization unit, using statistical software named "Createablockedrandomisationlist statistical software". Patients are randomly divided into three groups: A, Teachback education group, B, education group, and C, control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Individual training to complete individual learning and group training to use the experiences of others and save time

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular Center
Street address
Rajaei Heart and Vascular Center, Niayesh Highway,Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.RHC.REC.1399.142

Health conditions studied

1

Description of health condition studied
Myocardial Infraction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Self-efficacy score
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Sullivan Self-Efficacy Questionnaire

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group 1 (Teach Back training group): In this group, feedback-based training is done individually on myocardial infarction, diet, medications, activities and symptoms. The duration of each training session is one hour a day for two days.
Category
Lifestyle

2

Description
Intervention group 2: In this group, group training is held in groups of three about myocardial infarction, medications, diet, activity and symptoms. The duration of each training session is one hour a day for two days.
Category
Lifestyle

3

Description
Control group: control group will receive routine ward training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei Cardiovascular Training and Research Center
Full name of responsible person
Maryam Rezaei
Street address
Rajaei Heart and Vascular Center, Niayesh Highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 86 3367 5188
Fax
+98 21 2204 2026
Email
rezaeinurse.maryam@gmail.com
Web page address
https://fa.irct.ir/user/trial/55529/update/recruitment_center

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaei Heart and Vascular Center
Full name of responsible person
Dr. Majid Maleki
Street address
Rajaei Heart and Vascular Center, Niayesh Highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
maleki@rhc.ac.ir
Web page address
https://fa.irct.ir/user/trial/55529/update/sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaei Heart and Vascular Center
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
Rajaei Heart and Vascular Center
Full name of responsible person
Maryam Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaei Heart and Vascular Center, Niayesh Highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 86 3367 5188
Fax
+98 21 2204 2026
Email
rezaeinurse.maryam@gmail.com
Web page address
https://fa.irct.ir/user/trial/55529/update/public_queries_contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
RajaeiHeart and Vascular Center
Full name of responsible person
Mohammad Javad Alamzadeh Ansari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaei Heart and Vascular Center, Niayesh Highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
009821239212071
Fax
+98 21 2204 2026
Email
mj.aansari@gmail.com
Web page address
https://fa.irct.ir/user/trial/55529/update/scientific_queries_contact

Person responsible for updating data

Contact
Name of organization / entity
Rajaei Heart and Vascular Center
Full name of responsible person
Maryam Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaei Heart and Vascular Center, Niayesh Highway, Valiasr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 86 3367 5188
Fax
+98 21 2204 2026
Email
rezaeinurse.maryam@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making participants unidentifiable
When the data will become available and for how long
Access started in 2020
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of documents for scientific research
From where data/document is obtainable
Email: rezaeinurse.maryam@gmail.com Contact number 09180079172
What processes are involved for a request to access data/document
Requested documents will be sent by email.
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