The Evaluation of the Effectiveness of the First phase of Cardiac Rehabilitation on the Frequency of Readmission and Quality of Life in Patients Who Undergoing CABG
Determining the effectiveness of the first phase of rehabilitation on frequency of readmission and quality of life in patients who undergoing CABG
Design
A hundred eligible patients included in the study through available sampling, after a thorough explanation of the objectives of the study and taking informed consent, They were assigned into two groups of control (n = 50) and intervention (n = 50) by the random numbers table method
Settings and conduct
The present study will be performed at the Shahid Rajaei Educational Center. Blinding won't be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The time of hospitalization must be at least 24 hours; the person must have undergone the coronary artery bypass grafting surgery; having stable hemodynamic condition according to the physician diagnosis; having a history of hospitalization at least once in the past 6 months. Non-inclusion criteria: The Patient's unwillingness to participate in the study; the patient have been resuscitated within the first 24 hours after admission; the reason for the patient's hospitalization is consultation and physician visit.
Intervention groups
Intervention group :face to face education will be done in four 15-minute sessions by the rehabilitation nurse.Content of education sessions: Session 1: Education of coronary artery and lung anatomy by using images. 2: Education on diet and medication. 3:Lifestyle changing, smoking cessation and exercise importance.4:training about warning signs of cardiovascular diseases , physical activity, sexual activity, exercise in the range of motion and walking
control group:They will not attend training sessions.
Main outcome variables
Readmission; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171223038015N2
Registration date:2020-03-27, 1399/01/08
Registration timing:retrospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Fatemeh Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
frahimi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the Effectiveness of the First phase of Cardiac Rehabilitation on the Frequency of Readmission and Quality of Life in Patients Who Undergoing CABG
Public title
The Effectiveness of the First phase of Cardiac Rehabilitation on the Frequency of Readmission and Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The Time of hospitalization must be at least 24 hours
The person must have undergone the coronary artery bypass grafting surgery
Having Stable hemodynamic condition according to the physician diagnosis
Having a history of hospitalization at least once in the past 6 months
Exclusion criteria:
The patient's unwillingness to participate in the study
The patient have been resuscitated within the first 24 hours after admission
The reason for the patient's hospitalization is consultation and physician visit
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
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
Ethics Committee of Alborz University of Medical Sciences
Street address
No.9, Dara Town, East Pone avenue, North Yasaman street
City
Karaj
Province
Alborz
Postal code
3197635141
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.ABZUMS.REC.1398.146
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Readmission
Timepoint
Before and after the intervention
Method of measurement
Hospital Information System
2
Description
Quality of Life
Timepoint
Before and after the intervention
Method of measurement
SF 36 Quality of Life Questionnaire; MCNEW Quality of Life Questionnaire; WHO Quality of Life Questionnaire; Questionnaire of dietary; pharmacological and physical activity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: face to face education will be done in four 15-minute sessions by the rehabilitation nurse. Content of education sessions includes: Session 1: Education of coronary artery and lung anatomy by using images.2: Education on Diet and medication.3:Lifestyle changing, smoking cessation and exercise importance.4:training about warning signs of cardiovascular diseases, physical activity, sexual activity, exercise in the range of motion and walking
Category
Rehabilitation
2
Description
Control group: They do not receive any intervention and only in the first and last sessions of the study , their readmission rate and quality of life will be assessed by questionnaires.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei , Educational & Medical Center
Full name of responsible person
Fatemeh Rahimi
Street address
Shahid Rajaei Hospital; Shahid Beheshti avenue; Shahid Rajaei street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Mohamad Noorisepehr
Street address
Shahid Rajaei Hospital; Shahid Beheshti avenue; Shahid Rajaei street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Alborz University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Hospital; Shahid Beheshti avenue; Shahid Rajaei street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 264570030
Fax
+98 26 3457 0030
Email
frahimi110@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Hospital; Shahid Beheshti avenue; Shahid Rajaei street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi
Position
Critical Care Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Hospital; Shahid Beheshti avenue; Shahid Rajaei street
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Fax
+98 26 3455 4484
Email
frahimi110@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available