Effect of teach back education versus no education on self-care behaviors and quality of life in patients with myocardial infarction: a randomized clinical trial
Objectives: To assess the effect of teach back education versus no education on self-care behaviors and quality of life in patients with myocardial infarction.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with myocardial infarction who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) myocardial infarction for the first time; (b) Persian language; (c) literate without education of medical sciences.
Exclusion criteria: (a) not completing at least two educational sessions for any reason by patient; (b) having history of mental disorders.
Intervention group: Routine educations plus face to face education using Teach Back method for three sessions of an hour each.
Control group: Only routine educations.
Primary outcome: Assessing the self-care behaviors using questionnaire before and one month after intervention.
Secondary outcome: Assessing the quality of life using questionnaire before and one month after intervention.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601309014N91
Registration date:2016-02-06, 1394/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of teach back education versus no education on self-care behaviors and quality of life in patients with myocardial infarction: a randomized clinical trial
Public title
Effect of teach back education versus no education on self-care behaviors and quality of life in patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: (a) myocardial infarction for the first time; (b) Persian language; (c) literate without education of medical sciences.
Exclusion criteria: (a) not completing at least two educational sessions for any reason by patient; (b) having history of mental disorders.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-01-27, 1394/11/07
Ethics committee reference number
IR.UMSHA.REC.1394.431
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Assessing the self-care behaviors
Timepoint
before and one month after intervention
Method of measurement
using questionnaire
Secondary outcomes
1
Description
Assessing the quality of life
Timepoint
before and one month after intervention
Method of measurement
using questionnaire
Intervention groups
1
Description
Routine educations plus face to face education using Teach Back method for three sessions of an hour each
Category
Other
2
Description
Only routine educations
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Behnaz Moghadari Kousha,
Street address
Farshchian Hospital, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Behnaz Moghadari Kousha,
Position
Nursing Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0160
Fax
Email
bmoghadarikoosha@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Mohsen Salavati
Position
Nursing Trainer
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0160
Fax
Email
salavatimohsen42@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)