The effects of application of Prochaska's stages of change model in education of
coronary artery bypass grafting patients on quality of life, lipid profile & some
psychological complications of CABG, Shiraz 2012
Objective:the effect of application of Prochaska,s stages of change model in education of coronary artery bypass grafting patients on quality of life, lipid profile & some psychological complications of CABG.Design:randomised clinical trial.Inclusion criteria:Has only CABG surgery;
Exclusion criteria:History of CABG surgery; Has severe and life-threatening diseases alongside with coronary artery disease such as CVA and cancer.Method:the study population:post CABG patients attending selected Shiraz hospitals.Sample size:80.Intervention: after introducing the study and complete the consent form by patients researcher gather the basic information includes: laboratory test(lipid profile) and questionnaires(demografic data, quality of life, anxiety and depression and stages of change) then the patients are divided into two control and experimental group by randomization.
Education based on stages of change model of Prochaska was done for experimental group for 8 weeks.The control group only recieved routine programs.Two months after intervention laboratory test,quality of life, anxiety and depression, and stages of change of all the patients re-assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307162621N13
Registration date:2014-01-17, 1392/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Marzieh Moattari
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
moattarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-11-20, 1392/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of application of Prochaska's stages of change model in education of
coronary artery bypass grafting patients on quality of life, lipid profile & some
psychological complications of CABG, Shiraz 2012
Public title
The effect of education on coronary artery bypass grafting patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Has only CABG surgery; Residence in shiraz city or province; Access to telephone follow-up program by the researcher; Ability to read and write; Ability to understand the content based on the researcher,s judgment; Willing to participate in the study; Exclusion criteria: History of CABG surgery; Family members have expertise in medical sciences field; Have severe and life-threatening diseases alongside with coronary artery disease such as CVA and cancer; Have hearing problems; Have psychiatric or cognitive disorders.
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science,Zand st.
City
Shiraz
Postal code
Approval date
2013-01-26, 1391/11/07
Ethics committee reference number
6428
Health conditions studied
1
Description of health condition studied
Coronary Artery Disease
ICD-10 code
Z95.1
ICD-10 code description
presence of aortocoronary bypass graft
Primary outcomes
1
Description
Quality of life
Timepoint
Before and 2 months after intervention
Method of measurement
Mac New questionnaire
2
Description
Anxiety and Depression
Timepoint
pre test and post test (2 months after intervention)
Method of measurement
Hospital Anxiety and Depression Scale
3
Description
Triglyceride
Timepoint
Before and 2 months after intervention
Method of measurement
mg\dl
4
Description
Stages of change of patients
Timepoint
Before and 2 months after intervention
Method of measurement
Stages of change allgoritm
5
Description
Cholesterol
Timepoint
Before and 2 months after intervention
Method of measurement
mg\dl
6
Description
Cholesterol / High Density Lipoprotein (HDL)
Timepoint
Before and 2 months after intervention
Method of measurement
---
7
Description
Low Density Lipoprotein (LDL) / High Density Lipoprotein (HDL)
Timepoint
Before and 2 months after intervention
Method of measurement
---
8
Description
Body Mass Index (BMI)
Timepoint
Before and 2 months after intervention
Method of measurement
Weight / ( Height)2
9
Description
Smoking
Timepoint
Before and 2 months after intervention
Method of measurement
Demografic Form
Secondary outcomes
empty
Intervention groups
1
Description
Education based on stages of change model of Prochaska for intervention group took 8 weeks.These educations started immediately after discharge and continued in 2,4,6,8 weeks.
Category
Behavior
2
Description
Control group took routine educations.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Dr. Masih Shafa
Street address
Cardiac Surgery ICU, Namazi hospital, Namazi Square
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Dr. Masih Shafa
Street address
Cardiac Surgery ICU, Shahid Faghihi hospital, Zand street
City
Shiraz
3
Recruitment center
Name of recruitment center
Alzahra heart center
Full name of responsible person
Dr. Masih Shafa
Street address
Cardiac Surgery ICU, Alzahra heart center, Astaneh street
City
Shiraz
4
Recruitment center
Name of recruitment center
MRI hospital
Full name of responsible person
Dr. Masih Shafa
Street address
Cardiac Surgery ICU,MRI hospital,Chamran Blv.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Shiraz University of Medical Sciences
City
Shiraz
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PHD in Nursing, Faculty Member, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PHD in Nursing, Faculty Member, Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Moattari
Position
PHD in Nursing, Faculty Member of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Namazi square
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
moattarm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)