Healthy lifestyle plays a key role in improving cardiovascular risk factors and prevents deaths from heart attacks. Healthy lifestyle contributes to the treatment of cardiovascular diseases and leads to favorable outcomes after coronary angioplasty, one of the treatment options for cardiovascular patients. The main purpose of this study is to investigate the effect of education on lifestyle in patients after coronary angioplasty. The approach is a clinical trial with randomized sampling which survey the lifestyle and risk factors for cardiovascular disease in three stages before, immediately after and one month after education, in 60 patients who underwent coronary angioplasty for the first time. Inclusion criteria are as: age of people must be more than 35 years and less than 70 years; only once has the experience of coronary angioplasty; people must have literacy and the ability to read, write and answer questions; people must have no specific illnesses requiring hospitalization in the hospital; they must have no history of open heart surgery and women should not be pregnant.
The exclusion criteria are: people must have not participated in more than one education session of the researcher. The life style is measured by life-style questionnaire which is useful for heart patients and risk factors are evaluated by blood tests including FBS, HbA1c, Chol, TG, HDL, LDL, Vit D3, and Body Mass Index (BMI) and blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070334867N1
Registration date:2017-08-05, 1396/05/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Sara Khodabandehlooie
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 9127
Email address
sarakhodabandeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Bahman Clinic
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of healthy-lifestyle education on cardivascular risk factors in coronary patients undergoing angioplasty
Public title
Effect of healthy-lifestyle education on cardivascular risk factors in coronary patients undergoing angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of people must be more than 35 years and less than 70 years; Only once has the experience of coronary angioplasty; People must have literacy and the ability to read, write and answer questions; People must have no specific illnesses requiring hospitalization in the hospital (such as cancer, stroke); People must have no history of open heart surgery; Women who are not pregnant. Exclusion criteria: People must have not participated in more than one training session of the researcher.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Street address
Intersection of Valiasr and Nayesh Streets
City
Tehran
Postal code
1985717443
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SBMU.PHNM.1395.699
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
FBS, HbA1c, Chol, TG, HDL, LDL, Vit D 3 and blood pressure, BMI.
Timepoint
Before the intervention immediately after the intervention and one month after the intervention
Method of measurement
In the first stage, before the intervention, blood tests are extracted from the patient's previous file. In the next stage, after the intervention and one month after the intervention, blood samples are taken from the blood sample in the laboratory and blood tests are repeated. The height, weight and blood pressure of the subjects are measured by the researcher using the instrument of blood pressure, the meter and constant scale
Secondary outcomes
empty
Intervention groups
1
Description
The education intervention consists of 6 sessions, the first session is 45 minutes and the next sessions are 30 minutes. The individual or group interviews will be performed as face-to-face with feedback lectures and Q & A. A education package (pamphlet and brochure) will be given to the participants.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart clinic of Bahman hospital
Full name of responsible person
Sara Khodabandehlooie
Street address
Shahrak Gharb Iranzamin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Harert clinic of Bahman Hospital
Full name of responsible person
Dr Davood Kazemisaleh
Street address
Shahrak Gharb Iranzamin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Harert clinic of Bahman Hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Heart clinic of Bahman Hospital
Full name of responsible person
Sara Khodabandehlooie
Position
Nurse
Other areas of specialty/work
Street address
Shahrak Gharb Iran zamin
City
Tehran
Postal code
Phone
+98 21 8249 9556
Fax
Email
sarakhodabandeh@smbu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Khodabandehlooie
Position
Community health nursing MSc student
Other areas of specialty/work
Street address
Intersection of Niayesh and Valiasr Streets
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
saralooie@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Sara Khodabandehlooie
Position
Community health nursing MSc student
Other areas of specialty/work
Street address
Intersection of Niayesh and Valiasr Streets
City
Tehran
Postal code
Phone
00
Fax
Email
sarakhodabandeh@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)