Protocol summary
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Study aim
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Investigating the effect of smartphone educational applications on disease perception self-care behavior, and self-efficacy in patients undergoing percutaneous coronary intervention.
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Design
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A randomized, controlled with a control group, parallel groups, single-blind, randomized. we will use the block random allocation method for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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perception of self-care behavior, and self-efficacy
General information
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Reason for update
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change from double-blinded to single-blinded.
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Acronym
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IRCT registration information
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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
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Registration date
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2023-01-21, 1401/11/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-04-03, 1401/01/14
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Expected recruitment end date
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2022-07-11, 1401/04/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of smartphone educational application on patients undergoing percutaneous coronary intervention
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data analyser won't have any information about the assigned group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-28, 1401/09/07
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Ethics committee reference number
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Shahed.REC.1401.102
Health conditions studied
1
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Description of health condition studied
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angioplasty
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ICD-10 code
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Z95.5
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ICD-10 code description
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Presence of coronary angioplasty implant and graft
Primary outcomes
1
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Description
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Disease perception
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Timepoint
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Before intervention and 4 weeks after intervention
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Method of measurement
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Brief illness perception questionnaire (BIPQ)
Secondary outcomes
1
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Description
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Self-care behavior
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Timepoint
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Before intervention and 4 weeks after intervention
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Method of measurement
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Self-Care Miller Scale
2
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Description
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Self-efficacy
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Timepoint
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Before intervention and 4 weeks after intervention
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Method of measurement
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Self-efficacy Sullivan scale
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: patients who receive only the usual medical intervention, routine rehabilitation training, and practice during this period.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahed University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Some of the statistical data is available after being unidentifiable
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When the data will become available and for how long
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The access period is up to after the publication of the results.
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To whom data/document is available
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Data is available to academic researchers.
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Under which criteria data/document could be used
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The use of information for academic research projects is allowed
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From where data/document is obtainable
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Requests for specific information should be sent by Nahid Rejeh (email: nrejeh@yahoo.com)
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What processes are involved for a request to access data/document
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Requests for specific information should be sent by Nahid Rejeh (email: nrejeh@yahoo.com)
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Comments
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