Protocol summary

Study aim
Determining the effect of continuous care model on self-efficacy and treatment compliance in patients undergoing coronary bypass graft
Design
Clinical trial with a control group, with parallel groups, without blinding, randomized, on 80 patients.
Settings and conduct
The two hospitals under the supervision of Shahid Beheshti University of Medical Sciences will be randomly selected, one to select the intervention group and the second control group, and further, random block sampling will be done in two intervention and control groups. After surgery, the intervention group of patients undergoing graft surgery can receive special care based on follow-up care model, and the control group can receive only routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 65 years old, not in critical or emergency conditions, 24 hours have passed since admission, no debilitating disease, able to communicate and not suffering from known physical and mental diseases, access to a smartphone with the ability to install a messenger. Exclusion criteria: not attending two sessions (or more) out of the total number of sessions, participating in another educational program, entering the acute phase of the disease and needing to be re-hospitalized, not answering all the questions.
Intervention groups
In the intervention group, patients will receive health care based on training based on the continuous care model, including four stages of familiarization, sensitization, control, and evaluation, but the control group will receive only common care.
Main outcome variables
-Self-efficacy in patients undergoing coronary bypass surgery -Adherence to Treatment in patients undergoing coronary bypass surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230924059499N1
Registration date: 2023-10-31, 1402/08/09
Registration timing: registered_while_recruiting

Last update: 2023-10-31, 1402/08/09
Update count: 0
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Anis Kunani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3262 4715
Email address
aniskunani3611@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-17, 1402/07/25
Expected recruitment end date
2023-12-16, 1402/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Continuous Care Model on Self-Efficacy and Adherence to Treatment in Patients Undergoing Coronary Bypass Graft
Public title
The Effect of Continuous Care Model on Self-Efficacy and Adherence to Treatment in Patients Undergoing Coronary Bypass Graft
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years Patients undergoing coronary bypass graft surgery for the first time Being alert Not being in dire and emergency situations 24 hours have passed since the patient was admitted No debilitating disease Not preventing speech, hearing and vision and able to establish communication and cooperationIt Is the absence of physical and mental diseases that affect the quality of life, such as dialysis or other mental problems, such as complications and problems that require medication or a special diet Access to a smartphone with the ability to install messenge
Exclusion criteria:
Do not attend two (or more) meetings out of the total number of meetings People who have participated in another educational program during the research People who enter the acute phase of the disease and need to be re-hospitalized Transfer from the desired research unit to another unit Withdrawal from participating in the study Failure to answer all questions in the questionnaire
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation and the list of blocks will be obtained with the help of R software. In this method, the number of people assigned to each group is almost equal. In this method, blocks are formed based on the variables in question. Block randomization works by randomizing participants into blocks, so that an equal number are assigned to each group.Equal numbers of participants are included in the intervention and control groups at consecutive but equal intervals. After each patient is hospitalized for corner bypass graft surgery, according to the block of four prepared in the first stage, each patient will be randomly assigned to group A (intervention) or B (control group). For example, after randomly selecting a block such as ABAB block, patients are randomly placed in the intervention, control, intervention, and control groups, and the next patients are placed in the BBAA block as control, control, intervention, and intervention groups. After creating a random sequence, sampling must be done by hiding the created sequence. In such a way that before assigning an individual, the assigned group is not specific for the samples. This can be done by putting a random sequence inside the envelope and choosing the non-transparent envelope by people.In this method, first a random sequence is created, then based on the size of the research sample, a number of envelopes are prepared and each of the created random sequences is recorded on a card and the cards are placed in the envelopes in order. . In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order.Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened in order and the group The allocation of that participant is revealed. Each patient's code will be assigned. People are assigned to the desired group in the order of their entry into the study and randomly through randomized blocks
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Tehran, Vali Asr St., intersection of Ayat A... Hashemi Rafsanjani Highway, in front of Heart Hospital
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.044

Health conditions studied

1

Description of health condition studied
Coronary artery bypass graft
ICD-10 code
I25.70
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris

Primary outcomes

1

Description
Esteka's general self-efficacy
Timepoint
Measuring self-efficacy at the beginning of the study and 56 days after the start of the intervention
Method of measurement
Estaka General Self-Efficacy Questionnaire

2

Description
Adherence to treatment
Timepoint
Measurement of adherence to treatment at the beginning of the study and 56 days after the start of the intervention
Method of measurement
Modanlo adherence to treatment Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group received training related to the continuous care model, which includes four stages of familiarization, sensitization, control and evaluation, in the form of individual and group training, one session before surgery and 3 sessions after surgery.
Category
Rehabilitation

2

Description
The control group received routine ward care
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Anis Kunani
Street address
No. 72, Shahid Shahbazi St
City
Kohdasht
Province
Lorestan
Postal code
6841775355
Phone
+98 66 3622 4715
Email
AnisKunani3611@ sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Anis Kunani
Street address
No. 72, Shahid Shahbazi St
City
Kohdasht
Province
Lorestan
Postal code
6841775355
Phone
+98 66 3622 4715
Email
AnisKunani3611@ sbmu.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
Tehran-Shahid Chamran Highway - Yemen St. - Arabi St
City
Tehran
Province
Tehran
Postal code
4631- 19395.
Phone
+98 21 2243 9788
Email
urm@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
Anis Kunani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 72, Shahid Shahbazi St
City
Kohdasht
Province
Lorestan
Postal code
6841775355
Phone
+98 66 3262 4715
Fax
Email
Aniskunani3611@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anis Kunani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 72, Shahid Shahbazi St
City
Kohdasht
Province
Lorestan
Postal code
6841775355
Phone
+98 66 3622 4715
Email
Aniskunani3611@ sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Anis Kunani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 72, Shahid Shahbazi St
City
Kohdasht
Province
Lorestan
Postal code
6841775355
Phone
+98 66 3262 4715
Fax
Email
Aniskunani3611@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...