Protocol summary

Study aim
Determining the effect of tailored web-based education on self-care behaviors and quality of life in patients with acute coronary syndrome
Design
A controlled clinical trial with parallel groups, unblinded, randomized, on 60 patients. Randomization into groups will be performed using a block randomization method.
Settings and conduct
A study of web-based education in patients with acute coronary syndrome was conducted in the cardiac care unit of Valfajr Hospital. In this study, the McNew Quality of Life Questionnaire and the Miller Self-Care Behavior Questionnaire were used during hospitalization, discharge, and two months after discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with acute coronary syndrome (stable and unstable angina, myocardial infarction with/without ECG changes) admitted to the intensive care unit. Exclusion criteria: Patients who do not consent to participate in the study.
Intervention groups
Control group: McNew quality of life and Miller self-care questionnaires will be completed by patients upon admission. Then, patients will receive routine education during hospitalization and discharge, and the questionnaires will be completed again during discharge and two months after discharge. Intervention group: McNew quality of life and Miller self-care questionnaires will be completed before the intervention begins. First, a patient-centered needs assessment will be conducted before the start of education for patients. Then, the educational content tailored based on the needs assessment will be uploaded to the website and made available to patients. In addition, patients will receive routine education during hospitalization and discharge orally by a nurse. And patients will receive web-based education from the time of hospitalization until two months after discharge.
Main outcome variables
Self-care behaviors and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250121064471N1
Registration date: 2025-02-19, 1403/12/01
Registration timing: prospective

Last update: 2025-02-19, 1403/12/01
Update count: 0
Registration date
2025-02-19, 1403/12/01
Registrant information
Name
Mahsa Hajimirza
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3330 2033
Email address
mahhajimirza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-23, 1403/12/05
Expected recruitment end date
2025-04-22, 1404/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tailored web-based education on self-care behaviors and quality of life of patients with acute coronary syndrome
Public title
The effect of tailored web-based education on self-care behaviors and quality of life of patients with acute coronary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent to participate in the study should be obtained from patients before entering the study. Patients diagnosed with acute coronary syndrome (stable and unstable angina, heart attack with/without ECG changes) are admitted to the intensive care unit. Patients must have the necessary physical and cognitive abilities to participate in the research. Patients should have the ability to use smartphones and social networks. Patients must have access to home internet or a mobile phone. The patient or caregiver must be literate. Patients are between 30 and 70 years old. Patients should not have hearing or speech problems.
Exclusion criteria:
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of samples to groups is done using the block random method. In order to equalize the distribution of confounding variables such as gender and age, first, classes are created based on these variables as follows: female/male and age ≥50/<50 years. Then, using the block random method and using the block rand package of R software, a random sequence of random blocks will be formed as a sequence of letters A and B, and the samples will be placed in the study groups in a balanced manner.
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
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2024-04-09, 1403/01/21
Ethics committee reference number
IR.LUMS.REC.1403.030

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Improving quality of life in patients with acute coronary syndrome
Timepoint
At the beginning of the study, during discharge, and two months after discharge
Method of measurement
McNew Quality of Life Questionnaire for Patients with Myocardial Infarction

2

Description
self-care behaviors in patients with acute coronary syndrome
Timepoint
At the beginning of the study, during discharge, and two months after discharge
Method of measurement
Miller Self-Care Behaviors Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: McNew's quality of life and Miller's self-care questionnaires will be completed in paper form before the intervention begins. First, a patient-centered needs assessment will be conducted before the start of patient education. Then, the educational content tailored based on the needs assessment will be designed on a website, uploaded, and its URL link will be provided to the patients in the intervention group during their hospitalization in the CCU. In addition, patients will receive routine education during hospitalization and discharge orally by a nurse and physician. Patients will receive web-based education from the time of hospitalization until two months after discharge. After receiving the content, the questionnaires will be completed again by patients with acute coronary syndrome in the CCU during discharge and two months after discharge, in coordination with the patients, to the hospital in person to complete the questionnaires.
Category
Lifestyle

2

Description
Control group: The McNew Quality of Life and Miller Self-Care Questionnaires will be completed in paper form by patients upon admission. Then, patients will receive routine education during hospitalization and discharge orally by nurses and physicians, and the questionnaires will be completed again by patients with acute coronary syndrome, upon discharge from the CCU, and two months after discharge, in coordination with the patients, to complete the questionnaires in person at the hospital.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Walfajr Hospital
Full name of responsible person
Mahsa Hajimirza
Street address
Valfajr Hospital, Shahid Fayyaz Bakhsh St., Tarkhoran, Tafresh.
City
Tafresh
Province
Markazi
Postal code
3951635951
Phone
+98 86 3622 5444
Email
valfajr_hospital@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Bahram Karamehie
Street address
Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
b.kamarehie@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tahereh Tolabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
mahhajimirza@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Tahereh Tolabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
mahhajimirza@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mahsa Hajimirza
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences and Health Services, Anooshirvan Rezaei Square, Khorramabad.
City
Khorram abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Fax
Email
mahhajimirza@gmail.com

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
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