The effect of education and telephone follow-up on patients' adherence to the treatment regimen after myocardial infarction in patients admittede in Farshchian Cardiovascular Hospital of Hamadan in 2020
The aim of this study was to investigate the effect of educational intervention on adherence to the treatment regimen after myocardial infarction in patients admitted to Farshchian cardiovascular hospital in Hamadan in 2020.
Design
A randomized clinical trial with a control group, with three parallel groups
Settings and conduct
This study will be performed as a three-group clinical trial with the participation of 150 patients with myocardial infarction in Hamadan in 2020. Patients will be randomly assigned to be divided into three groups . In intervention group A , the necessary training will be provided using an booklet and face-to-face training . In the B intervention group, in addition to the above, patients will be monitored by telephone and vitual education for 3 months. Telephone calls will be made to patients following a follow-up twice a week for the first six weeks and then once a week for the second six weeks. There is no intervention in the control group and patients receive only routine care as usual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Reading and writing literacy, Access to landline or mobile phone and the ability to use it, Age 35 to 70 years
Exclusion criteria: No answering the phone (3 times), Lack of desire to continue participating in research
Intervention groups
In the intervention group A, the necessary training will be done by using the educational booklet for the importance of following the treatment regimes in the form of face-to-face training for each patient and also providing them with an educational booklet. In intervention group B , in addition to the above, patients will be monitored by telephone and virtual education for 3 months.
There is no intervention in the control group(C) and patients receive only routine care .
Main outcome variables
Adherence to the treatment regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N31
Registration date:2020-07-18, 1399/04/28
Registration timing:registered_while_recruiting
Last update:2020-07-18, 1399/04/28
Update count:0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education and telephone follow-up on patients' adherence to the treatment regimen after myocardial infarction in patients admittede in Farshchian Cardiovascular Hospital of Hamadan in 2020
Public title
The effect of educational intervention on patients' adherence to the treatment regimen
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 35 to 70 years
Access to landline or mobile phone and the ability to use it
Reading and writing literacy
Exclusion criteria:
Lack of desire to continue participating in research
No answering the phone (3 times)
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation will be done using a random number table. Patients will be randomly divided into three groups intervention(A and B) and control (C).
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
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.UMSHA.REC.1399.147
Health conditions studied
1
Description of health condition studied
Myocardial infarction
ICD-10 code
I21.01
ICD-10 code description
ST elevation (STEMI) myocardial infarction involving left main coronary artery
Primary outcomes
1
Description
A dherence to the treatment regimen
Timepoint
Two months after the educational intervention
Method of measurement
Questionnaire for following a treatment regimen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: The necessary training will be provided using an educational booklet for the importance of following treatment regimens as face-to-face training for each patient and also providing them with an educational booklet.
Category
N/A
2
Description
Intervention group B: Patients will be monitored by telephone for 3 months. Phone calls will be made to patients following a follow-up treatment regimen twice a week for the first six weeks and then once a week for the second six weeks.
Category
N/A
3
Description
Control group C: No intervention is performed and patients receive only routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian cardiovascular hospital
Full name of responsible person
Mehdi Molavi Vardanajni
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s_bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
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
Mehdi Molavi Vardanajni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
m.molavi@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