The effect of smartphone educational application on disease perception self-care behavior, and self-efficacy in patients undergoing percutaneous coronary intervention
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Protocol summary
A randomized, controlled with a control group, parallel groups, double-blind, randomized. we will use the block random allocation method for randomization.
A randomized, controlled with a control group, parallel groups, single-blind, randomized. we will use the block random allocation method for randomization.
A randomized, controlled with a control group, parallel groups, doublesingle-blind, randomized. we will use the block random allocation method for randomization.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، دو سویه کور، تصادفی شده. برای تصادفی سازی از روش تخصیص تصادفی بلوکی استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، یک سویه کور، تصادفی شده. برای تصادفی سازی از روش تخصیص تصادفی بلوکی استفاده خواهد شد.
کارآزمایی بالینی دارای گروه کنترل، باگروه های موازی، دویک سویه کور، تصادفی شده. برای تصادفی سازی از روش تخصیص تصادفی بلوکی استفاده خواهد شد.
General information
Double blinded
Single blinded
doublsingl
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1
1
1
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change from double-blinded to single-blinded.
change from double-blinded to single-blinded.
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تغییر از دو سویه کور به یک سویه کور
تغییر از دو سویه کور به یک سویه کور
The assignment of the groups will be done by someone out of the study and the investigator won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. Patients participating in the study do not know which control and intervention groups they belong to.
Data analyser won't have any information about the assigned group.
The assignment of the groups will be done by someone out of the study and the investigatorData analyser won't have any information about the assigned group. The group code of individuals will only be available to the lead researcher (supervisor) and the evaluators will not be aware of it. Patients participating in the study do not know which control and intervention groups they belong to.
تخصیص گروه توسط فردی خارج از مطالعه خواهد بود و محقق ارزیابی کننده پیامدها از گروه تخصیص یافته اطلاعی نخواهد داشت. کد گروه افراد فقط در اختیار محقق اصلی (استاد راهنما) خواهد بود که افراد ارزیابی کننده از آن اطلاع نخواهند داشت. بیماران شرکت کننده در مطالعه از اینکه در کدامیک از گروه های کنترل و مداخله قرار دارند مطلع نیستند.
آنالیز کننده داده نسبت به از گروه تخصیص یافته اطلاعی نخواهد داشت.
تخصیص گروه توسط فردی خارج از مطالعه خواهد بود و محقق ارزیابیآنالیز کننده پیامدهاداده نسبت به از گروه تخصیص یافته اطلاعی نخواهد داشت. کد گروه افراد فقط در اختیار محقق اصلی (استاد راهنما) خواهد بود که افراد ارزیابی کننده از آن اطلاع نخواهند داشت. بیماران شرکت کننده در مطالعه از اینکه در کدامیک از گروه های کنترل و مداخله قرار دارند مطلع نیستند.
Protocol summary
Study aim
Investigating the effect of smartphone educational applications on disease perception self-care behavior, and self-efficacy in patients undergoing percutaneous coronary intervention.
Design
A randomized, controlled with a control group, parallel groups, single-blind, randomized. we will use the block random allocation method for randomization.
Settings and conduct
By referring to the angioplasty department of Shahid Rajaei Hospital affiliated to Alborz Medical Sciences, patients are randomly assigned to intervention and control groups. The educational content application will be delivered to the patients in the intervention group, a smartphone follow-up. In the control group, patients receive only the usual medical intervention during this period.
Four weeks after the intervention, the questionnaires will be completed.
Participants/Inclusion and exclusion criteria
Age between 18 and 60 years old. Ability to read and understand the Persian language. Having healthy senses of hearing and sight. Having access to a smartphone and being able to use them. Having access to and the ability to use a smartphone. Do not participate in another study at the same time. For the first time, percutaneous coronary interventions have been performed. Suffering from any disease that cannot continue participating in the study. Failure to continue accessing the smartphone for any reason.
Intervention groups
The Intervention group: In addition to routine training after discharge, people will receive educational content based on mobile health through an application that can be installed on a smartphone. The application will contain educational materials based on the Leventhal self-regulatory model. The patients in the control group receive only the usual medical intervention, routine rehabilitation training, and practice during this period.
Main outcome variables
perception of self-care behavior, and self-efficacy
General information
Reason for update
change from double-blinded to single-blinded.
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N27
Registration date:2023-01-21, 1401/11/01
Registration timing:retrospective
Last update:2025-03-01, 1403/12/11
Update count:1
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of smartphone educational application on disease perception self-care behavior, and self-efficacy in patients undergoing percutaneous coronary intervention
Public title
The effect of smartphone educational application on patients undergoing percutaneous coronary intervention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 60 years old.
Able to read and write in Persian
Having sensory health of hearing and sight
Access to smart phones and being able to use smart phones (patient/ his or her care giver)
No simultaneous participation in research or other intervention
Not having a history of known psychological disorders
Exclusion criteria:
Having any disease, which is not able to continue participating in the study
lack of mobile phone access
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned into 2 groups using permuted block randomization with an allocation ratio of 2:2. Random allocation sequence will be determined using a computerized program (www.sealedenvelope.com).
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser won't have any information about the assigned group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
Shahed.REC.1401.102
Health conditions studied
1
Description of health condition studied
angioplasty
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
Disease perception
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Brief illness perception questionnaire (BIPQ)
Secondary outcomes
1
Description
Self-care behavior
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Self-Care Miller Scale
2
Description
Self-efficacy
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Self-efficacy Sullivan scale
Intervention groups
1
Description
Intervention group: After discharge remote learning through phone calls will be made for this group. Interventions include assessment of patient care, and providing advice and training necessary to perform self-care behavior, the application will contain educational materials based on the Leventhal self-regulatory model.
Category
Rehabilitation
2
Description
Control group: patients who receive only the usual medical intervention, routine rehabilitation training, and practice during this period.