Determining the effect of family-centered education on self-care behaviors in patients after acute myocardial infarction
Design
The number of samples in this study is 70 based on the sample size formula. Patients are selected by sampling method and are placed in two groups of control and intervention according to the table of random numbers.
Settings and conduct
This study will be performed on patients with acute myocardial infarction admitted to CCU wards of hospitals affiliated to Shiraz University of Medical Sciences. For the intervention group, family-centered education will be implemented in three sessions. Data collection tools include demographic information form and a specialized questionnaire to assess the self-care ability in heart patients of Kerni and Felicher. The specialized questionnaire will be completed in three stages before the intervention, one and two months after the completion of the internship in both groups. At the end of the three training sessions, patients will be given a checklist of daily activities, and patients will be followed up by telephone every two weeks until the questionnaire is completed.
Participants/Inclusion and exclusion criteria
being over 18 years old; Diagnosis and confirmation of myocardial infarction by a specialist physician; having a minimum literacy for the patient and active family member; fluency in Persian in the patient and active family member; no known mental illness in the patient and active family member; patient desire And an active family member to participate in the study
Intervention groups
In the intervention group, the intervention is held in the form of self-care training to the patient with an active family member in 3 sessions of 45-60 minutes. In the control group, no intervention will take place and they will receive only the usual care of the ward.
Main outcome variables
Self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211116053078N1
Registration date:2021-11-23, 1400/09/02
Registration timing:prospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Elham Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
e_taheri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-01, 1400/09/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered education on self-care behaviors of patients after acute myocardial infarction
Public title
The effect of family and patient education on care behaviors in patients with myocardial infarction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Active family member (according to the patient, a family member who is the main caregiver of the patient and spends the most time with her)
Having an age range above 18 years
Diagnosis and confirmation of myocardial infarction based on Ck mb-troponin I enzyme tests, ECG changes, clinical signs by a specialist doctor
Having the minimum literacy to read and write in the patient and active family member
Fluency in Persian language in the patient and active family member
Lack of known mental illness in the patient and active family member
The desire of the patient and active family member to participate in the study
Exclusion criteria:
Not wanting to continue participating in the study
Non-Iranian nationality
Living alone or in a nursing home
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by available sampling from among patients with acute myocardial infarction admitted to the CCU wards of selected hospitals who are eligible for admission and after selection by random allocation using a random number table will be divided into control and intervention groups. The letters a and b will be considered as code, so that the letter a will be assigned to one of the groups and the letter b to the other group. Samples will be selected from the same number of selected centers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a blind sur. The help of a researcher who is unaware of the intervention and control group will be used to collect questionnaires and evaluate the data.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2021-09-06, 1400/06/15
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1400.023
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-care behaviors
Timepoint
Before the intervention, one month and two months after the intervention
Method of measurement
Self-care behaviors questionnaire in heart patients from Carney and Fleischer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teaching self-care behaviors in three sessions to patients with acute myocardial infarction with an active family member.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital, Saadi Hospital, Al-Zahra Heart Hospital
Full name of responsible person
Elham Taheri
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
elhamtaheri32@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Kamyar Zomordian
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
nurs-midwif@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Taheri
Position
Master student in adult intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
e_taheri@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Taheri
Position
Master student in adult intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
e_taheri@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Taheri
Position
Master student in adult intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
e_taheri@sums.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
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' personal data can be shared after being unidentified and information about the main outcome.
When the data will become available and for how long
A few months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use the results of other research
From where data/document is obtainable
Taheri Elham
elhamtaheri32@yahoo.com
What processes are involved for a request to access data/document