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Studying the effect of using a mobile phone-based medication reminder program and sending educational SMS on medication adherence and quality of life of patients with Acute coronary syndrome discharge

Protocol summary

Study aim
Determining the Effect of a Mobile Phone–Based Medication Reminder Application and Educational Text Messaging on Medication Adherence and Quality of Life in Patients with Acute Coronary Syndrome
Design
✅ This randomized, single-blind, controlled clinical trial with parallel groups included 66 patients(33 in each group) with multiple sclerosis, randomly selected using Random Number Generator software and assigned to intervention and control groups via Random Allocation Software.
Settings and conduct
After Ethics Committee approval and IRCT registration, patients will be randomly assigned to intervention and control groups, and informed consent will be obtained. Questionnaires will be completed before and after the intervention, which is based on the nursing process and includes education on medication, nutrition, physical activity, myocardial infarction, and stress management.
Participants/Inclusion and exclusion criteria
Definite diagnosis of acute coronary syndrome Absence of major psychological disorders such as major depression, psychosis, etc. Ability to use a mobile phone and possession of a personal smartphone Ability to perform self-care, especially in taking prescribed medications Age between 35 and 65 years No hearing, visual, or other physical or sensory impairments No addiction to narcotics, alcohol, or psychotropic substances
Intervention groups
For patients in the intervention group, in addition to the routine education, the “DaruYad” application will be installed on their mobile phones. The researcher will install the application for each patient and enter the required information, including prescribed medications, into the program. Moreover, patients will receive short reminder text messages for one month after discharge. The control group will receive only the routine ward education provided before discharge
Main outcome variables
medication adherence and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251101067838N1
Registration date: 2025-11-26, 1404/09/05
Registration timing: registered_while_recruiting

Last update: 2025-11-26, 1404/09/05
Update count: 0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Fatemeh Fakharzadeh jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 2908
Email address
f.fakharzadeh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2026-02-19, 1404/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of using a mobile phone-based medication reminder program and sending educational SMS on medication adherence and quality of life of patients with Acute coronary syndrome discharge
Public title
Studying the effect of using a mobile phone-based medication reminder program and sending educational SMS on medication adherence and quality of life of patients with Acute coronary syndrome After discharge
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of acute coronary syndrome for the first time, confirmed by a cardiologist. No major psychological disorders such as major depression, psychosis, etc. Willingness of the patient to participate in the research. Ability to read and write Ability to use a mobile phone and possession of a personal smartphone capable of installing the medication reminder application used in the present study. Ability to perform self-care activities, especially adherence to prescribed medications. Age between 35 and 65 years No hearing, vision, or other physical and sensory disabilities. No addiction to drugs, alcohol, or psychoactive substances. No memory-related disorders or dementia. No participation in other educational programs or self-care intervention studies. Patient’s acknowledgment of having adequate financial means or family/social support to obtain prescribed medications during the study period.
Exclusion criteria:
Recurrence of acute and severe symptoms of the disease or acute complications of coronary syndrome (such as dysrhythmias and various types of heart blocks) requiring rehospitalization in intensive care units. Development of cognitive or psychological disorders during the study. Patient’s unwillingness to continue participation in the study. Death of the patient. Occurrence of acute events or crises affecting medication adherence and the patient’s quality of life, such as severe trauma, death of first-degree relatives, and similar situations.
Age
From 35 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, patients with acute coronary syndrome hospitalized in the cardiology wards of Peymanieh and Seyed Al-Shohada (AS) Hospitals affiliated with Jahrom University of Medical Sciences will be recruited using a convenience sampling method. Patients will be randomly assigned to the intervention group (33 participants) and the control group (33 participants) using the Random Allocation Software. The allocation of each patient will be done individually based on the randomization flowchart generated by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single-blinded, meaning that the data collector (research assistant) was unaware of the participants’ group allocation (intervention or control) at each stage.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Deputy for Research and TechnologyوAdministrative (Campus) Building,Jahrom University of Medical Sciences,End of Shahid Motahari Street,Jahrom, Fars Province, Iran
City
jahrom
Province
Fars
Postal code
7414846199
Approval date
2025-10-20, 1404/07/28
Ethics committee reference number
IR.JUMS.REC.1404.099

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
125.9
ICD-10 code description
Acute coronary

Primary outcomes

1

Description
Medication adherence
Timepoint
Before, immediately after the intervention, and two months after the intervention
Method of measurement
Morisky Medication Adherence Questionnaire

Secondary outcomes

1

Description
quality of life
Timepoint
Before, immediately after the intervention, and two months after the intervention
Method of measurement
MacNew Heart Disease Health-related Quality of Life Questionnaire

Intervention groups

1

Description
Intervention Group: For patients in the intervention group, in addition to the routine training provided to all patients before discharge, the DaruYad medication-reminder application will be installed on their mobile phones. The DaruYad application was designed by the Biomedical Engineering Department, Faculty of Medical Sciences and Technologies, Science and Research Branch, Islamic Azad University.The various components of the DaruYad software include: the login section, the current medications section, access for the pharmaceutical representative to the patient’s dedicated page, searching the prescribed medication, selecting the medication from the available pharmaceutical company database, and determining the administration instructions for the selected drug.Within the application, the medication dose, dosing interval (every few hours), registration of the first administration time (hour and minute), start date (year, month, and day), dosage form (for example, if the medication is a tablet and half a tablet must be taken), the patient’s medication quota, an audio alarm, and a clear image of the medication’s appearance and specifications are displayed.In addition, patients will receive short reminder text messages for one month after discharge.
Category
Behavior

2

Description
Control group: The control group will receive only the routine pre-discharge education provided in the ward, which includes recognizing warning signs, contacting emergency services immediately in case of symptom onset, rest and limitation of physical activity, indications for using nitroglycerin tablets and instructions for their administration, stress management, and appropriate dietary recommendations.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac Care Unit (CCU), Peymanieh Educational Hospital
Full name of responsible person
Fatemeh Fakharzadeh Jahromi
Street address
Peymanieh Hospital, Valiasr Street, Jahrom
City
jahrom
Province
Fars
Postal code
71677251542
Phone
+98 917 791 5687
Email
f.fakharzadeh@jums.ac.ir

2

Recruitment center
Name of recruitment center
Seyed Al-Shohada Hospital, Jahrom
Full name of responsible person
Fatemeh Fakharzadeh Jahromi
Street address
Seyed Al-Shohada Hospital, Shahid Motahari Boulevard, Jahrom
City
jahrom
Province
Fars
Postal code
71677251542
Phone
+98 71 5414 2000
Email
f.fakharzadeh@jums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Hossein Kargar Jahromi
Street address
✅ Deputy of Research and Technology, Jahrom University of Medical Sciences, Shahid Motahari Boulevard
City
jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 5447 4985
Email
hossein.kargarjahromy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Fakharzadeh jahromi
Position
Master of student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 401, Pars Complex 26, Alley 29/3, Motahari St., Fars Province, Jahrom City
City
Jahrom
Province
Fars
Postal code
7167758256
Phone
+98 71 5433 2908
Fax
Email
f.fakharzadeh@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr. Rasoul Eslami Akbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahrom University of Medical Sciences, Motahari Boulevard, Jahrom
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0409
Email
eslamiakbarrasool@ gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fatemeh Fakharzadeh jahromi
Position
Master of student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 401, Pars Complex 26, Alley 29/3, Motahari St., Fars Province, Jahrom City
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5433 2908
Fax
Email
f.fakharzadeh@jums.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
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