Comparison the effect of therapeutic engagement model and routine cardiac rehabilitation on the sense of coherence and medication adherence of patients undergoing coronary artery bypass graft surgery: a randomised clinical study
Determination of the efficacy of therapeutic engagement model and cardiac rehabilitation on adherence to treatment and sense of coherence of patients after coronary artery bypass graft surgery
Design
This study is a clinical trial. 72 patients undergoing coronary artery bypass graft surgery will assign in two groups, intervention and control by random block method.
Settings and conduct
This study will be carried out in Farshchian Cardiovascular Hospital, affiliated to the Hamadan University of Medical Sciences in Hamadan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients after coronary artery bypass grafting; desire to participate in the study. Exclusion Criteria: Heart Failure class III and IV; Positive exercise test; Severe musculoskeletal problems.
Intervention groups
Intervention group: Patients will receive a continuous care program for four months alongside a cardiac rehab program. control group: patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.
Main outcome variables
Sense of coherence; Adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012439N4
Registration date:2019-07-09, 1398/04/18
Registration timing:prospective
Last update:2019-07-09, 1398/04/18
Update count:0
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Fatemeh Pakrad
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4041
Email address
f_pakrad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of therapeutic engagement model and routine cardiac rehabilitation on the sense of coherence and medication adherence of patients undergoing coronary artery bypass graft surgery: a randomised clinical study
Public title
the effect of therapeutic engagement model and routine cardiac rehabilitation on the sense of coherence and medication adherence of patients undergoing coronary artery bypass graft surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients after coronary artery bypass graft surgery
patient's willingness to participate in educational programs based on a therapeutic engagement model
Exclusion criteria:
Heart Failure class III and IV
Severe musculoskeletal problems
Positive exercise test
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, from patients with coronary artery bypass graft surgery and having inclusion criteria, a sample is selected according to the convenience sampling method and based on balance block randomization method will be placed in cardiac rehabilitation group with education based on therapeutic engagement model and the cardiac rehabilitation group. For this purpose, four sheets of paper are provided by the researcher, writing on two sheets “1” for “first” and on two “2” for second”. The paper sheets will be pooled, placed in a container, and randomly will be drawn one at a time for each patient without replacement until all four sheets are drawn. Then, the four paper sheets will be placed back into the container and this action will be repeated until the sample size is reached.
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
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvd, Pajouhesh Sq
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.UMSHA.REC.1398.307
Health conditions studied
1
Description of health condition studied
Patients undergoing coronary artery bypass graft surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Adherence to treatment score
Timepoint
Before, one month and three months after the intervention
Method of measurement
Adherence to treatment questionnaire
Secondary outcomes
1
Description
Sense of Coherence score
Timepoint
Before, one month and three months after the intervention
Method of measurement
Sense of Coherence questionnaire
Intervention groups
1
Description
Intervention group: In the first intervention group, the intervention will be as follows: Upon introduction of the study and statement of the purposes, the patients will provide informed consents and complete the demographics form, adherence to treatment and sense of coherence questionnaires. Then, the therapeutic engagement model will be presented to the participants along with cardiac rehabilitation program for four months. At the end, one month and three months after intervention, adherence to treatment and sense of coherence questionnaires will be completed.
Category
Rehabilitation
2
Description
Control group: In this group, patients will receive cardiac rehabilitation according to the routine program rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Cardiac Center
Full name of responsible person
Fatemeh Pakrad
Street address
Shahid Fahmidah Blv., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
f_pakrad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Shahid Fahmidah Blv., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0320
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Pakrad
Position
Employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmidah Blv., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
f_pakrad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmidah Blv., Pajouhesh Sq.
City
Hamadn
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Pakrad
Position
Employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmidah Blv., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
f_pakrad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I must provide all information for the sponsoring institution.