Comparison the effect of family participated and common cardiac rehabilitation on quality of life in patients undergoing coronary artery bypass graft surgery
Objective: To determine the impact of family participated cardiac rehabilitation on quality of life in patients undergoing coronary artery bypass graft surgery in Hamadan Ekbatan hospital. Study design: Randomized. Sample Size: 60 patients. Study population: Patients undergoing Coronary Artery Bypass Graft Surgery. Major inclusion criteria: Ability to understand and speak Persian, Ability to complete the questionnaire and do the interviews, Presence of a family member beside patient, Range of age between 30 and 70 years old. Major exclusion criteria: Not refer to the rehabilitation center for any reason, existing from the low-risk patient`list. Intervention: The control group receives only routine cardiac rehabilitation program but families will participate in cardiac rehabilitation in intervention group. Primary outcomes: Quality of life in patients undergoing coronary artery bypass graft surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120811697N1
Registration date:2013-06-02, 1392/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Mahdi Torkamani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1824 9249
Email address
m.torkamani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-07-16, 1392/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of family participated and common cardiac rehabilitation on quality of life in patients undergoing coronary artery bypass graft surgery
Public title
The cardiac rehabilitation effects on quality of life after coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Ability to understand and speak Persian; Ability to complete the questionnaire and do the interviews; Presence of a family member beside patient; Range of age between 30 to 70 years. Exclusion Criteria: Not refer to the rehabilitation center for any reason; Out of the low-risk patients`list.
Age
From 30 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)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
As patients are referred to the center gradually so randomization is to select the patients by Coin toss.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh st.
City
Hamadan
Postal code
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
4018/9/35/16/پ/ر
Health conditions studied
1
Description of health condition studied
The condition after Coronary Artery Bypass Graft Surgery.
ICD-10 code
121.0
ICD-10 code description
Ischemic Heart Disease.
Primary outcomes
1
Description
Quality of life
Timepoint
At the beginning of intervention and 2 month after the end of intervention
Method of measurement
Macnew Heart Related Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this study, during routine cardiac rehabilitation in center for intervention group, education and home based rehabilitation is doing with cooperation of patient`s family at home as well. Educations include emphasizing on walking, diet, stress management and having adequate sleep.
Category
Rehabilitation
2
Description
For control group, only routine cardiac rehabilitation program is conducted at Center.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Ekbatan Hospital
Full name of responsible person
Mahdi Torkamani
Street address
Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research and Technology of Hamadan University of Medical Sciences.
Full name of responsible person
Ali Ghaleiha
Street address
Shahid Fahmideh St.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research and Technology of Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Mehdi Torkamani
Position
MSc Student in Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St.
City
Hamadan
Postal code
Phone
+98 81 1838 0572
Fax
Email
mpt5458@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Mehdi Torkamani
Position
MSc Student in Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmideh st.
City
Hamadan
Postal code
Phone
+98 81 1838 0572
Fax
Email
mpt5458@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Mahdi Torkamani
Position
MSc Student in Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan university of medical sciences, Shahid Fahmideh st.
City
Hamadan
Postal code
6516948153
Phone
+98 81 1824 9249
Fax
Email
mpt5458@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)