The effect of educational intervention based on the theory of planned behavior on self-management behavior of patients with acute coronary syndrome (ACS)
Determining the effect of educational intervention based on the theory of planned behavior on self-management of patients with acute coronary syndrome (ACS)
Design
Patients will be divided into control and intervention groups . The sample size includes 63 in control & 63 in intervention group
Settings and conduct
The current study is an educational intervention that will be conducted on patients with ACS referred to the hospitals of Kerman University of Medical Sciences. Patients will be randomly divided into two control & intervention groups. Then, in addition to routine care, the intervention group will participate in training sessions based on the structures of the theory of planned behavior, and the control group will receive only routine care. The data collection tool will be a researcher-made questionnaire.data will be analyzed by SPSS26.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. All conscious patients diagnosed with ACS
2. No participating in other studies or educational sessions similar to this research during the last 6 months
3. Having a smart phone and being able to work with it
Exclusion criteria:
1. Not having minimum reading and writing literacy
2. Inability to take care of oneself
3. History of psychological disorder
4. Congenital heart disease
5. Inability to answer questions due to illness
Intervention groups
After randomly dividing the patients into two control and intervention groups, in addition to routine care, the intervention group will participate in training sessions based on the structures of the theory of planned behavior, and the control group will receive only routine care.
The effect of educational intervention based on the theory of planned behavior on self-management behavior of patients with acute coronary syndrome (ACS)
Public title
The effect of educational intervention based on the theory of planned behavior on self-management behavior in heart attack patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All conscious patients, referred to this hospital, in whom the clinical and paraclinical diagnosis of ACS has been confirmed and are now ready to be discharged
No participating in other studies or training sessions similar to this research during the last 6 months
Having a smart phone and the ability to work with it
Exclusion criteria:
Lack of minimum reading and writing literacy
Inability to salf-care (dependence on others) for any reason except ACS based on Barthel's ADL tool (completely dependent (0-8 points), relative dependence (9-12 points), Complete independence (13-20 points)} is determined.
History of psychological disorder (use of antipsychotic drugs) which is determined based on the self-report of the patient or the patient's companion
Cardiovascular disease as a complication of another chronic disease
Congenital heart disease
Inability to answer questions due to the disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The study is an educational intervention. By referring to the relevant ward, patients are selected based on the inclusion and exclusion criteria in the study and are placed in the control and intervention groups based on even and odd days, respectively. The control group receives the usual care of the ward. In addition to the usual interventions, the intervention group participates in training sessions designed based on the constructs of the theory of planned behavior.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Jahad Blvd. Ebn Sina Avenue, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
76177
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.KMU.REC.1401.255
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome (ACS)
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
2
Description of health condition studied
Self-management
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Attitude
Timepoint
At the beginning of the study (before the start of intervention) and 2 months after intervention
Method of measurement
A researcher-made questionnaire which reliability and validity have been confirmed.
2
Description
Perceived norm
Timepoint
At the beginning of the study (before the start of intervention) and 2 months after intervention
Method of measurement
A researcher-made questionnaire which reliability and validity have been confirmed.
3
Description
Perceived behavioral control
Timepoint
At the beginning of the study (before the start of intervention) and 2 months after intervention
Method of measurement
A researcher-made questionnaire which reliability and validity have been confirmed.
4
Description
behavioral intention
Timepoint
At the beginning of the study (before the start of intervention) and 2 months after intervention
Method of measurement
A researcher-made questionnaire which reliability and validity have been confirmed.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is an educational intervention that has been prepared using reliable and up-to-date sources and has been approved by experts. Before the intervention, the overall score of each of the theoretical constructs as well as the overall score of the patients' self-management behavior is determined using a questionnaire. Then, in addition to routine care, the intervention group will participate in 5 training sessions (0.5 to 1 hour). After the implementation of the educational program for the intervention group and two months have passed, the questionnaire will be completed for them to determine the effect of the intervention on the patients under study.
Category
Other
2
Description
Control group: This group will only receive routine care. The questionnaire will complete twice by them. Once at the beginning of the study and the second time 2 months after filling the first questionnaire. At the end of the work and after filling the second questionnaire, in order to comply with ethics, educational materials are also provided to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital (Kerman)
Full name of responsible person
Dr Sakineh Sabzevari
Street address
Kosar Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Web page address
https://sh.kmu.ac.ir
2
Recruitment center
Name of recruitment center
Afzahipour hospital (kerman)
Full name of responsible person
Dr Sakineh Sabzevari
Street address
Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
Afzahipourhospital@kmu.ac.ir
Web page address
https://ah.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Street address
Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
S_Sabzevari@kmu.ac.ir
Web page address
https://www.kmu.ac.ir
Grant name
Grant code / Reference number
با هزینه شخصی است
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal expenses
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Skineh Sabzevari
Position
Associate professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
s_sabzevari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Position
Associate professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft Bagh Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7617796777
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Position
Associate Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
7617796777
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A summary of the project in the form of an end of project report and article
When the data will become available and for how long
Completion of the plan
To whom data/document is available
Researchers in the field of health sciences
Under which criteria data/document could be used
Literature review, evidence-based medicine and nursing, modeling for similar diseases
From where data/document is obtainable
To published articles and contact authors
What processes are involved for a request to access data/document