Comparison of the Effectiveness of a healthy lifestyle empowerment program on improving health-related quality of life and adherence to health-promoting behaviors in two intervention and control groups of patients undergoing coronary artery bypass graft
Determination of the impact of a healthy lifestyle empowerment program on health-related quality of life and adherence to health-promoting behaviors in coronary artery bypass graft patients
Design
This randomized controlled trial was conducted on 97 undergoing CABG (49 in control group and 48 in intervention group) selected by classified block randomization
Settings and conduct
This study was conducted in Shahid Rajaie. The healthy lifestyle empowerment program (HELP) was implemented in four 45-60-minute training sessions held by the first researcher. The sessions were held in groups of three to five in the education office of male and female surgical wards and included face-to-face training with the the contents of the dimensions of health promoting behaviours including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. The post-discharge telephonic follow-ups were performed in the fourth and eighth weeks after discharge to repeated educational content and to answer participants` questions.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- aged 45-65 years,
2-undergoing first-time CABG
3-full hearing and speech ability
4- lack of diagnosed mental illness as documented in the case file
5- willingness to participate in the study and giving written informed consent, and no sign of drug abuse
Exclusion criteria:
1- failure to participate in at least half of the training sessions
2- not completing questionnaires
3- death during the HELP or the data collection process
4- postoperative complication and readmission
Intervention groups
Patients undergoing coronary artery bypass graft
Main outcome variables
health-related quality of life
adherence to health-promoting behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171213037860N1
Registration date:2020-03-01, 1398/12/11
Registration timing:retrospective
Last update:2020-03-01, 1398/12/11
Update count:0
Registration date
2020-03-01, 1398/12/11
Registrant information
Name
Parvaneh Vasli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5367
Email address
parvanehvasli@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-05-21, 1398/02/31
Trial completion date
2019-05-21, 1398/02/31
Scientific title
Comparison of the Effectiveness of a healthy lifestyle empowerment program on improving health-related quality of life and adherence to health-promoting behaviors in two intervention and control groups of patients undergoing coronary artery bypass graft
Public title
Effectiveness of a healthy lifestyle empowerment program on health-related quality of life and adherence to health-promoting behaviors in patients undergoing coronary artery bypass graft
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
aged 45-65 years,
undergoing first-time CABG,
full hearing and speech ability,
lack of diagnosed mental illness as documented in the case file,
willingness to participate in the study, giving written informed consent,
no sign of drug abuse.
Exclusion criteria:
failure to participate in at least half of the training sessions
not completing questionnaires
death during the program or the data collection process, and postoperative complication and readmission.
postoperative complication and readmission
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
86
Actual sample size reached:
97
Randomization (investigator's opinion)
Randomized
Randomization description
classified block randomization using coin toss
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is a single-blind study. This means that the study participants were not aware of which study groups they were in.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
ValiAsr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.SBMU.PHNM.1396.1008
Health conditions studied
1
Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
health-related quality of life - adherence to health-promoting behaviors
Timepoint
Befor and 3 months after healthy lifestyle empowerment program
Method of measurement
Information about Health-related quality of life (HRQoL) was collected by the 12-item Short-Form Health Survey (SF-12) and information about adherence to HPBs was collected by the Persian version of Health-Promoting Lifestyle Profile II (HPLP-II)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients undergoing coronary artery bypass graft. The intervention for this group was the healthy lifestyle empowerment program (HELP). HELP as an intervention was implemented in four 45-60-minute training sessions held by the first researcher. The sessions were held in groups of three to five in the education office of male and female surgical wards and included face-to-face training and sharing of experiences among patients. The contents of the HELP gram were chosen based on the latest scientific literature, with the cooperation of cardiologists, psychologists, and nutrition and religious experts, and covered different dimensions of health promoting behaviors including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. The chosen contents were compiled into an educational booklet and a pamphlet. To reinforce the effect of the HELP, post-discharge telephonic follow-ups were performed in the fourth and eighth weeks after discharge. In these follow-ups, the contents of the HELP were briefly repeated and questions of the patients were answered.
Category
Lifestyle
2
Description
Control group: patients undergoing coronary artery bypass graft. The Participants of control group received routine discharge training, which recommends a low salt diet, 30-minute daily walk, and adherence to the medication regime prescribed by the physician.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
Parvaneh vasli
Street address
ValiAsr Street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2276
Fax
+98 21 2204 2026
Email
parvanehvasli@yahoo.com
Web page address
http://rhc.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Thesis grant
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh vasli
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
021-88655366-9
Fax
+98 21 8865 5363
Email
p-vasli@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/index.jsp?pageid=27653&p=1
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh Vasli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
021-88655367-9
Fax
+98 21 8865 5363
Email
p-vasli@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/index.jsp?pageid=27653&p=1
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvaneh Vasli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Vali Asr Ave., Niayesh Cross Road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
021-88655366-9
Fax
+98 21 8865 5363
Email
p-vasli@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/index.jsp?pageid=27653&p=1
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document