Effect of education and telephone follow-up after hospital discharge versus control group on self-care behaviors in patients with myocardial infarction: a randomized clinical trial
To assess the effect of education and telephone follow-up after hospital discharge versus control group on self-care behaviors in patients with myocardial infarction
Design
This is a randomized clinical trial, phase II, in which 116 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with myocardial infarction referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 30 to 70 years,
Myocardial infarction,
Literate,
The possibility of telephone call to the patients or their family
Exclusion criteria:
Other concurrent chronic diseases,
Inability of self-care
Intervention groups
Intervention group:
Routine cares and trainings after myocardial infarction plus one session face to face training along with pamphlets and educational CD, providing information about the signs and symptoms need for returning, following medication instructions, diet follow-up, allowable physical range, risk factors for re-myocardial infarction, and the effects of stress
Control group:
Just routine cares and trainings after myocardial infarction
Main outcome variables
Primary outcome:
Assessing the self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N363
Registration date:2020-07-28, 1399/05/07
Registration timing:prospective
Last update:2020-07-28, 1399/05/07
Update count:0
Registration date
2020-07-28, 1399/05/07
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
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education and telephone follow-up after hospital discharge versus control group on self-care behaviors in patients with myocardial infarction: a randomized clinical trial
Public title
Effect of education and telephone follow-up after hospital discharge versus control group on self-care behaviors in patients with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 30 to 70 years,
Myocardial infarction,
Literate,
The possibility of telephone call to the patients or their family
Exclusion criteria:
Other concurrent chronic diseases,
Inability of self-care
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:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-07-25, 1399/05/04
Ethics committee reference number
IR.UMSHA.REC.1399.409
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Assessing the self-care behaviors
Timepoint
Before the intervention and weekly after the treatment for 8 weeks
Method of measurement
Using standard Miler self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine cares and training after myocardial infarction plus one session face to face training along with pamphlets and educational CD, providing information about the signs and symptoms need for returning, following medication instructions, diet follow-up, allowable physical range, risk factors for re-myocardial infarction, and the effects of stress
Category
Behavior
2
Description
Control group: Just routine cares and training after myocardial infarction
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Mehran Salmani Ghabeshi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
gabeshi1347@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mehran Salmani Ghabeshi
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
gabeshi1347@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Masood Khdaveisi
Position
Community Health Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khodaveisimasoud@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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