Determining the effect of partnership-based education on adherence to the treatment plans of patients undergoing open heart surgery
Design
A randomized,double blind,parallel group,controlled clinical trial on 86 patients.R software will be used for randomization.
Settings and conduct
The educational intervention(5 sessions for a week)is performed in the post-ICU of cardiac surgery of Imam Khomeini Hospital in Tehran, which has 13 beds.The collection of data are performed by a trained nurse outside the research team and analyst will not be aware of how individuals are assigned to the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria are non-emergency surgery,performing heart surgery for the first time,ability to attend physically in educational sessions,have a minimum literacy rate,possibility of telephone access to follow up program.Exclusion criteria are previous experience of caring for a patient undergoing heart surgery,known mental illness.
Intervention groups
Intervention involves providing partnership-based education in which the patient and family member participate in educational sessions at the same time.The total number of sessions consists of 5 sessions for a week and the time of each session is between 20 to 40 minutes and includes two sessions of individual training with the presence of a patient and a family member and 3 sessions of group training including groups of 4 to 6 including patients and their family members.The content of the sessions includes the reason for the importance of following the medication regimen and the role of proper diet after surgery,as well as the time of starting chest physiotherapy,exercise and the time of starting sexual activity and the need to participate in cardiac rehabilitation program.The control group receives routine ward care.
Main outcome variables
Adherence to dietary;physical activity and medication plan
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200714048104N2
Registration date:2020-08-29, 1399/06/08
Registration timing:registered_while_recruiting
Last update:2020-08-29, 1399/06/08
Update count:0
Registration date
2020-08-29, 1399/06/08
Registrant information
Name
Foroozan Atashzadeh-Shoorideh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2520
Email address
f_atashzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-04, 1399/04/14
Expected recruitment end date
2020-10-20, 1399/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of partnership-based education on adherence to the treatment plans of patients undergoing open heart surgery
Public title
partnership-based education and adherence to the treatment plans
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing non-emergency coronary artery bypass graft surgery and valve replacement surgery
Performing open heart surgery for the first time
Ability to read of educational booklet
Ability to attend physically in the educational sessions
Possibility of telephone access to follow up program
First-degree members of the patient who are in close contact with him / her and who are responsible for caring for the patient after discharge from the hospital
Have a minimum literacy rate
Exclusion criteria:
Previous experience of caring for a patient undergoing heart surgery for a family member
known mental illness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment sequence and list of blocks will be obtained using R software. The block method is used for sampling. According to the total number of samples required for the study, which is 86 patients (43 patients in the intervention group (A) and 43 patients in the control group (B)), 21 blocks with a size of four includes two groups A and B will be randomly selected using the software, such as (ABAB). Then 86 pockets (43 pockets A and 43 pockets B) will be prepared. According to a list of blocks, a trained person outside the research team is responsible for randomly assigning patients. After admission of each patient to the intensive care unit, will be given a pocket and assigned to Group A (intervention) or B (control group), and the sample process will be performed sequentially until the end of completion of sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the study, it is not possible to blind participants and implement the intervention. But, the collection of demographic information and adherence of therapeutic plan assessment questionnaires (outcome assessment) are performed before and after the intervention by a trained nurse outside the research team and data analyst will not be aware of the assignment of individuals to groups.
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
Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2020-04-30, 1399/02/11
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.112
Health conditions studied
1
Description of health condition studied
Cardiac disease
ICD-10 code
I51.6
ICD-10 code description
Cardiovascular disease, unspecified
Primary outcomes
1
Description
adherence to dietary plan
Timepoint
Before intervention and 8 weeks after end of intervention
Method of measurement
questionnaire of adherence to dietary plan
2
Description
adherence to physical activity plan
Timepoint
Before intervention and 8 weeks after end of intervention
Method of measurement
questionnaire of adherence to physical activity plan
3
Description
adherence to medication plan
Timepoint
Before intervention and 8 weeks after end of intervention
Method of measurement
standard 8-item Morisky Medication Adherence scale (MMAS-8)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes education with partnership-based approach that will consist of 5 sessions including two sessions of individual training and three sessions of group training for (20 to 45) minutes.The first session includes individual training with the presence of the patient and the caregiver. The duration of the first session will be between 20 and 35 minutes, and information about the type of surgery, the necessary preparations before surgery, the reason for transfer to the ICU, the duration of hospitalization in the intensive care unit, the reason for using connections such as chest tubes and pacemakers , Will be given to them face to face with a focus on questions and answers. Then, three group training sessions (30 to 45 minutes) after transferring the patient to the post-ICU ward with the presence of patients and caregivers will be done in groups of 4 to 6 people. Group educations are speech-based with PowerPoint slides, group discussion, questions and answers and practical presentations. The content of the educations include the importance of medication regimen after surgery, the role of the proper diet after surgery, start time of the chest physiotherapy program, exercises, time to start sexual activity and the need to participate in a cardiac rehabilitation program. The last session is an individual training session (20 to 25 minutes) for each patient with the caregiver and the content of the education includes a description of the schedule of subsequent referrals after discharge and taking into account the warning signs and early and delayed complications after surgery, how to deal with these complications and referring to the hospital for a quick follow-up, necessary periodical tests, at the end, educational booklet and medication pamphlet were given to the participants.
Category
Other
2
Description
Control group: The control group uses routine hospital training and in order to observe ethics in research, the control group participants received a booklet and educational pamphlet
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Foroozan Atashzadeh-Shoorideh
Street address
Imam Khomeini Hospital Complex,Dr. Gharib Street; at the end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8163 3686
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
next to Ayatollah Taleghani Hospital, Shahid Arabi St.Yemen St, Shahid Chamran Highway , Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
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
Neda Sanaie
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Opposite to Rajaee Heart Hospital,Cross of Vali-Asr and Hashemi Rafsanjani Highway,Vali-Asr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nedasanaie@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Foroozan Atashzadeh-Shoorideh
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Opposite to Rajaee Heart Hospital,Cross of Vali-Asr and Hashemi Rafsanjani Highway,Vali-Asr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
f_atashzadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Opposite to Rajaee Heart Hospital,Cross of Vali-Asr and Hashemi Rafsanjani Highway,Vali-Asr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nedasanaie@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data analysis information
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Nursing researchers and students
Under which criteria data/document could be used
It has not been decided yet
From where data/document is obtainable
Email to nedasanaie@sbmu.ac.ir
What processes are involved for a request to access data/document