Comparative evaluation of discharge planning based on continuous care model and routine cardiac rehabilitation on the health related outcomes of patients undergoing coronary artery bypass graft surgery
Comparison of the efficacy of discharge planning based on continuous care model and cardiac rehabilitation on health related outcomes of patients after coronary artery bypass graft surgery
Design
This study is conducted as a combined embedded study. The qualitative part of the study of the clinical trial type and 132 patients undergoing coronary artery bypass graft surgery were assigned in three groups (intervention 1, intervention 2 and control) by random block method and random number table. This study is a single blinded in which the analysers, are not informed of the intervention received by the patient.
Settings and conduct
This study will be carried out in Farshchian Cardiac center, 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; Proportion to one member of family to patient. Exclusion Criteria: Heart Failure class III and IV; Positive exercise test; Severe musculoskeletal problems.
Intervention groups
Intervention group 1: Patients will receive a continuous care program for two months alongside a cardiac rehab program. Intervention group 2: patients will receive cardiac rehabilitation according to the routine programme rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program. Control group: patients will not receive any treatment with their personal pleasure, so they will not participate in cardiac rehab and will not be educated.
Main outcome variables
Quality of life; Depression, Anxiety and Stress; Readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012439N3
Registration date:2019-01-16, 1397/10/26
Registration timing:prospective
Last update:2019-01-16, 1397/10/26
Update count:2
Registration date
2019-01-16, 1397/10/26
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
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of discharge planning based on continuous care model and routine cardiac rehabilitation on the health related outcomes of patients undergoing coronary artery bypass graft surgery
Public title
Comparative evaluation of discharge planning and cardiac rehabilitation on the health outcomes of patients undergoing coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients after coronary artery bypass graft surgery
The family and patient's willingness to participate in educational programs based on a continuous care model
Close relationship of family member with patient
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
Data analyser
Sample size
Target sample size:
132
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 sampling method and based on balance block randomization method will be placed in cardiac rehabilitation group with education based on continuous care model (first) and the cardiac rehabilitation group (second). 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. However, patients in the control group (third) were reluctant to participate in cardiac rehabilitation would be estimated within 2 months and ranked in the random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
The trial would be carried out as single blind so that the statistical analyst was unaware of the trial groups until the data would be analysed.
Placebo
Not used
Assignment
Parallel
Other design features
This study will take place in two phases of quantitative and qualitative. In the quantitative phase, a clinical trial is conducted and in a qualitative phase, the nested mixed method is conducted through directed content analysis. Patients in the first group will be interviewed during the study and the data will be analysed through thematic analysis.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Nasr (Ghisha) Bridge, Jalale Al-Ahmad Great way
City
Tehran
Province
Tehran
Postal code
14115-333
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.MODARES.REC.1397.183
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
Quality of life score in the short form questionnaire 36 questions
Timepoint
Before and two months after the intervention
Method of measurement
Short form questionnaire of quality of life
2
Description
Stress score in depression, anxiety and stress questionnaire
Timepoint
Before and two months after the intervention
Method of measurement
Depression Anxiety and Stress Scale
3
Description
Depression score in depression, anxiety and stress questionnaire
Timepoint
Before and two months after the intervention
Method of measurement
Depression Anxiety and Stress Scale
4
Description
Anxiety score in depression, anxiety and stress questionnaire
Timepoint
Depression Anxiety and Stress Scale
Method of measurement
Depression Anxiety and Stress Scale
Secondary outcomes
1
Description
Readmission
Timepoint
After the end of the intervention
Method of measurement
Through phone call with the patient
Intervention groups
1
Description
Intervention group 1: 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, quality of life questionnaire and Depression, anxiety and stress scale. Then, the Continuous Care Model will be presented to the participants along with cardiac rehabilitation program for two months. The Continuous Care Model consists of four stages: (1) orientation, (2) sensitization, (3) control, and (4) evaluation. At the end of two months, quality of life questionnaire and Depression, anxiety and stress scale will be completed.
Category
Rehabilitation
2
Description
Intervention group 2: In this group, patients will receive cardiac rehabilitation according to the routine programme rehabilitation center. Patients will participate 3 sessions a week for one hour during one month in a supervised rehab program.
Category
Rehabilitation
3
Description
Control group: patients will not receive any treatment with their personal pleasure, so they will not participate in cardiac rehab and will not be educated. At the end of the intervention, educational package will be given ethically.
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 Blvd., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
6519953596
Phone
+98 81 3838 1740
Email
f.pakrad@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medical Sciences, Tarbiat Modares University