Investigating the effect of educational intervention based on mobile phone application on self-care behaviors of patients after Coronary artery bypass surgery
General purpose of the study
Determining the effect of educational intervention through a mobile phone application on self-care behaviors after coronary heart transplant surgery in patients undergoing coronary heart transplant surgery.
Design
Clinical trial with a control group, without blinding, randomized, 3 study phases on 86 patients, consecutive sampling
Settings and conduct
In the first phase of this study, the educational content needed to design a mobile phone-based application for self-care of patients who have undergone coronary artery bypass surgery will be discussed. The data collected in this phase will be used as educational content of the educational application in the second phase of the study. Evaluation will be done in the third phase of the study. which will include the technical evaluation of the mobile application and the evaluation of the educational intervention through the mobile application on self-care behaviors after coronary heart transplant surgery in patients undergoing coronary heart transplant surgery in patients referred to the heart surgery center in Sanandaj.
Participants/Inclusion and exclusion criteria
The conditions for entering the study include the willingness and ability to participate in the study, having a smart mobile phone and the ability to work with mobile software and perform coronary artery bypass surgery. The conditions for not entering the study include having a neurological or cognitive disorder that cannot use a mobile phone, emergency coronary artery bypass surgery, and previous elective coronary artery surgery.
Intervention groups
Patients referred to heart surgery center in Sanandaj who are Electively undergoing coronary artery bypass surgery
Main outcome variables
Adherence to drug therapy; Wound care; Diet; Physical activity; Return visit and follow-up by the Doctor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230722058876N1
Registration date:2023-12-11, 1402/09/20
Registration timing:registered_while_recruiting
Last update:2023-12-11, 1402/09/20
Update count:0
Registration date
2023-12-11, 1402/09/20
Registrant information
Name
Saeed Yarahmadi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4547
Email address
saeed.yarahmadi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of educational intervention based on mobile phone application on self-care behaviors of patients after Coronary artery bypass surgery
Public title
Investigating the effect of educational intervention based on mobile phone application on self-care behaviors of patients after Coronary artery bypass surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness and ability to continue participating in research
Having a smartphone and the ability to install software and use it
Living in Sanandaj city within 6 months from the time of entering the study
Coronary artery bypass surgery and discharge from the hospital
Ability to provide informed consent
Exclusion criteria:
Participant suffering from a specific disease that makes it impossible for her to participate in the research
Patients undergoing emergency surgery
Patients who have neurological or cognitive impairments such as vision, hearing or cognitive impairment that impair their ability to use a digital device.
Receive training before entering the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
From the list of participants who meet the entry criteria and based on the determined sample size, the test and control groups will be selected randomly from among the participating patients. Sampling method will be available in this study in such a way that the patients referred for elective coronary artery bypass surgery in the open heart surgery center of Sanandaj city, who have the conditions to enter, will be included in the study and in order to make the research conditions uniform. For two intervention and control groups, it will be using sequential sampling method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tarbit Modares University
Street address
Faculty of Medicine, Tarbiat Modares University, Jalal Al-Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
331-14115
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.MODARES.REC.1402.124
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass surgery
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft
Primary outcomes
1
Description
Self-care behaviors after coronary artery bypass graft surgery
Timepoint
Before discharge, 1 and 3 months after surgery
Method of measurement
Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery
2
Description
Knowledge of self-care behaviors after coronary artery bypass graft surgery
Timepoint
Before discharge, 1 and 3 months after surgery
Method of measurement
Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery
3
Description
Attitudes towards self-care behaviors after coronary artery bypass surgery
Timepoint
Before discharge, 1 and 3 months after surgery
Method of measurement
Questionnaire of knowledge, attitude and application of self-care in patients undergoing coronary artery bypass surgery
Secondary outcomes
1
Description
Rehospitalization due to heart disease
Timepoint
After discharge, one and three months after surgery
Method of measurement
Number of hospital readmissions due to heart disease
2
Description
Mortality due to heart disease
Timepoint
One year after surgery
Method of measurement
Death rate from heart disease
Intervention groups
1
Description
Intervention group: Self-care educational content in the form of a mobile application in different ways (videos, text, images) and in different formats (tests, Lightner reminder box, gamification, reminders, alarms, progress monitoring, control of vital signs) which includes medication reminders (recognition Medicine, side effects of each medicine, amount and time of taking each medicine), how to care for the wound, diet control, reminder of physical activity, amount of physical activity, use of gamification and reminder of when to visit the doctor, will be in the right hand of these patients.
Category
Rehabilitation
2
Description
Control group: Patients referred to the heart surgery center who underwent elective surgery and need emergency surgery. If they want to participate in the study and meet the entry criteria, after providing explanations and receiving informed consent, they will be randomly placed in the control group and will receive the routine training of the department.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Surgery Center of Tohid Sanandaj Hospital
Full name of responsible person
Saeed Yar Ahmadi
Street address
Sanandaj, Griashan Street, Tawheed Hospital
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3328 6112
Fax
+98 87 3322 7118
Email
saeed.yarahmady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdulzadeh
Street address
Faculty of Medicine, Tarbiat Modares University, Jalal Al-Ahmad St., Tehran
City
Tehran
Province
Tehran
Postal code
33114115
Phone
+98 21 8285 3590
Email
med@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
99
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
2
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Omid Zarei
Street address
Kurdistan University of Medical Sciences, Sanandaj, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Phone
+98 87 3366 4645
Email
journal@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tarbiat Modares University
Proportion provided by this source
1
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
Tarbiat Modares University
Full name of responsible person
Saeed Yarahmadi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
33114115
Phone
+98 21 8288 4547
Fax
Email
saeed.yarahmadi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeed Yarahmadi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
333114115
Phone
+98 21 8288 4547
Fax
Email
saeed.yarahmadi@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeed Yarahmadi
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
33114115
Phone
+98 21 8288 4547
Fax
Email
saeed.yarahmadi@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Part of the data (information about the main outcome and secondary outcomes) can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
By citing the source, the use of documents is allowed.
From where data/document is obtainable
Saeed Yarahmady, email: saeed.yarahmady@gmail.com, contact number 09188789172
What processes are involved for a request to access data/document
Sending an email or calling the researcher's phone number and fully explaining the process through which the information of this research is going to be used.