The effect of continuce care model on self-concept and adherence to therapy in patients undergoing coronary artery bypass grafting in Seyed-al-Shohada educational hospital of Urmia during 2018-2019
The effect of continuce care model on self-concept and adherence to therapy in patients undergoing coronary artery bypass grafting in Seyed-al-Shohada teaching hospital of Urmia
Design
This project is implemented in two groups of testing and control. Samples are assigned to groups in the form of blocked strain. Each group will consist of thirty samples and a total of sixty samples. The study will be in the form of a clinical trial.
Settings and conduct
The present study is designed to evaluate the effects of ongoing care and self-concept on compliance with the treatment of patients undergoing coronary artery bypass grafting. The sample size will be 60 patients who will be randomly divided into two groups receiving intervention and control. This study is in the center Educational treatment will be done in Seyed-ul-Shohada, Urmia.
Participants/Inclusion and exclusion criteria
Patients in this study will be included as research samples that have the following features:
1. Do not undergo any other surgery during the bypass surgery
2. No psychiatric illness over the past 6 months, according to the patient
3. Not having speech, audible and perceptual problems
4- Age 30 to 70 years
Non-arrival conditions
1-Patient's dissatisfaction
2. Unavailability of the patient
Intervention groups
Continuance care is done in 4 steps for the intervention group. One-time follow-up is done 1-2 times by telephone or presence.After 8-12 weeks, the questionnaire is re-completed for both groups. The control group uses routine training and routine treatment of the treatment center.
Main outcome variables
Continuance care; self-concept; Adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181105041560N2
Registration date:2019-06-30, 1398/04/09
Registration timing:retrospective
Last update:2019-06-30, 1398/04/09
Update count:0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
Yusef Haghighi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
hagigym@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-20, 1398/01/31
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuce care model on self-concept and adherence to therapy in patients undergoing coronary artery bypass grafting in Seyed-al-Shohada educational hospital of Urmia during 2018-2019
Public title
The Effect of Continuous Care Modeling on Self-Concept and Adherence to Treatment in Patients with Coronary-Related Transplantation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
During the bypass surgery, they will not undergo any other surgery
Not having psychiatric illness over the past 6 months, according to the patient
Not having spoken, audible and perceptual problems
Age of 30 to 70 years
Exclusion criteria:
Unavailability of the patient
Dissatisfaction of patient
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
Patients will be selected based on inclusion criteria and then classified into two groups receiving intervention and control group, using the random block method in quadruple blocks based on the obtained list. To generate random sequences in this clinical trial, http://www.graphpad.com/quickcalcs/index.cfm will be used.
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
Ethic committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Jahad Ave., Urmia, I.R. Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.UMSU.REC.1397.352
Health conditions studied
1
Description of health condition studied
Investigating the effect of continuous care on self-concept and adherence to treatment of patients undergoing coronary artery bypass grafting
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Continuance care
Timepoint
At the beginning of the study and 3 months after the start of the study
Method of measurement
Continuance care questionnaire
2
Description
Self-concept
Timepoint
At the beginning of the study and 3 months after the start of the study
Method of measurement
Beck’s Self Concept Test
3
Description
Adherence to treatment
Timepoint
At the beginning of the study and 3 months after the start of the study
Method of measurement
Treatment adherence questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Continuance care, which is considered as a native model of Iran, will be conducted by telephone within 8 to 12 weeks after surgery. Continuance care has 4 stages including awareness, sensitization, control and evaluation. Transparency of stages will take 30-40 minutes, before discharge consultation will take 30-40 minutes, and consultation after discharge at home by phone will take 20-30 minutes. After the completion of the study, the adherence to treatment will be measured again.
Category
Treatment - Drugs
2
Description
Control group: In the control group, there is no surplus intervention except routine care , and the nursing and doctor's recommendations will be based on the routine of surgery ward and after the completion of the practice, adherence to the treatment will be checked again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed-al-Shohada educational hospital of Urmia
Full name of responsible person
Yusef.Hagigy Mogadam
Street address
Jahad Avenue, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7000
Email
hagigym@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yusef.Hagigy Mogadam
Street address
Jahad Aveniue, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7000
Email
hagigym@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Yusef.Hagigy mogadam
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahad Aveniue, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
Jahad Ave., Urmia, I
Phone
+98 44 3275 4962
Email
hagigym@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Behnam.Askary
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
17 SHahrivar Aveniue
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 443237590714
Email
askaribehnam@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yusef.Hagigy Mogadam
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Jahad Avveniue, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
Post code: 57147
Phone
+98 44 31937243 -04432754962
Email
hagigym@yahoo.com
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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing sampling and analyzing data, the study is published as a paper
When the data will become available and for how long
5 months
To whom data/document is available
29/5000
Researchers and nursing students
Under which criteria data/document could be used
In order to use and publish the results of the study through the legal procedures approved by the Urmia University of Medical Sciences
From where data/document is obtainable
Urmia University of Medical Sciences
What processes are involved for a request to access data/document