Improvement of self-care and quality of life in patients with acute coronary syndrome
Design
In this study, 70 eligible patients with acute coronary syndrome admitted to the Coronary Care Unit of Modarres Hospital of Saveh were chosen purposefully and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
The present study will be conducted at Modarres Hospital of Saveh and on patients with acute coronary syndrome. Samples and data analyzers will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of acute coronary syndrome; 20 to 60 years old; not having of previous history of hospitalization in the Coronary Care Unit; reading and writing skills; not having hearing and vision impairments
Exclusion criteria:candidate candidates for angiography or coronary artery bypass graft surgery; cardiac heart failure class 4; unwillingness of the patient's participant to do the study
Intervention groups
Intervention group: self-care education program perform for the intervention group during three sessions of 30 to 45 minutes with a one-day interval during one week.
Control group: control group samples do not receive any intervention
Main outcome variables
The quality of life of patients with acute coronary syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161223031522N6
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on the quality of life of patients with acute coronary syndrome
Public title
The effect of self-care education on the quality of life of patients with acute coronary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of acute coronary syndrome
20 to 60 years old
Not having of previous history of hospitalization in the Coronary Care Unit
Reading and writing skills
Not having hearing and vision impairments
Exclusion criteria:
Stage 4 of cardiac failure
Patients to candidates for angiography or coronary artery bypass graft surgery
Unwillingness of patients to participant in the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into intervention and control groups using randomized block allocation method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blind and clinical trial. Data and data analyzers will not be aware of the random allocation method in the intervention and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Committee of Saveh University of Medical Sciences
Street address
Shariati St, Madar Sq
City
Saveh
Province
Markazi
Postal code
3918698786
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.SAVEHUMS.REC1396.07
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Quality of life questionnaire score
Timepoint
Before intervention, immediately after intervention and two months after intervention
Method of measurement
(Short-form 36) SF-36 Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: self-care education program perform for the intervention group during three sessions of 30 to 45 minutes with a one-day interval during one week
Category
Lifestyle
2
Description
Control group: control group samples do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Dr Hojjat Tamizi
Street address
Modarres St, Modarres Sq
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3395
Email
info@savehums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Hamidreza Baradaran
Street address
Shariati St, Madar Sq
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3395
Email
info@savehums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Saveh 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
Saveh University of Medical Sciences
Full name of responsible person
Neda Fayazi
Position
Instructor, faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati St, Madar Sq
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3395
Email
nedafayazi10@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Saveh University of Medical Sciences
Full name of responsible person
Neda Fayazi
Position
Instructor, faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shariati St, Madar Sq
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3395
Email
nedafayazi10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
وحید ناصری سلحشور
Position
دانشجوی کارشناسی ارشد
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Basij Sq, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
vahidnaseri1994@yahoo.com
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 18 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
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Neda Fayazi, MSc of Nursing, Faculty of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran.
E-mail address: nedafayazi10@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.