Determination effect of Teach back education on treatment adherence and readmission in patients with acute coronary syndrome in Zahedan University of Medical Sciences,2019
Design
This clinical trial is community-based, non-blind with control group and 70 acute coronary syndrome patients will be randomly assigned into two groups.
Settings and conduct
In the intervention group, Teach back education will be conducted in three individual sessions. the duration of the education will be based on the patient's tolerance level between 30 and 45 minutes. In the control group, routine care has been performed and there will be no intervention in this group. One and three months after the intervention, the treatment adherence tools and re-admission form will be completed in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-The first patient's admission to the diagnosis of acute coronary syndrome 2-Passing 24 hours after admission patients 3-Living in Zahedan City 4-Lacking disabling disease 5-Non-impairment in speech, hearing and vision 6-Able to communicate and collaborate 7-Lack of mental disorders 8-The absence of the patient or a family member in the medical department ؛Exclusion criteria: 1-Lack of desire to cooperate 2-Lack of participating in the educational sessions
Intervention groups
In the intervention group, Teach back education will be provided in three sessions individually. We ask each patient to express their educational content in their own language. Patient readmission is investigated in both intervention and control groups within three months of intervention. The control group will receive only routine education at the time of discharge by nurses in the department. One and three months after intervention, treatment adherence tool for both groups will be completed.
Main outcome variables
Treatment adherence،Readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043013N1
Registration date:2019-03-20, 1397/12/29
Registration timing:registered_while_recruiting
Last update:2019-03-20, 1397/12/29
Update count:0
Registration date
2019-03-20, 1397/12/29
Registrant information
Name
hamid reza Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 7753
Email address
h.azizi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-16, 1397/12/25
Expected recruitment end date
2019-06-15, 1398/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Teach back education on treatment adherence and re-admission in patients with acute coronary syndrome
Public title
Effect of teach back education on treatment adherence and re-admission in patients with acute coronary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The first patient's admission to the diagnosis of acute coronary syndrome
Passing 24 hours after admission patients
Lacking disabling disease
Non-impairment in speech, hearing and vision
Able to communicate and collaborate
Lack of mental disorders
The absence of the patient or a family member in the medical department
Living in Zahedan City
Exclusion criteria:
Lack of desire to cooperate
Lack of participating in the educational sessions
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
70 individuals will be randomly assigned to two groups.The sample size of the color card is provided in two colors: red and blue. Cards are arranged randomly. Each card is assigned to a patient, depending on the color, into the control or intervention group.
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 Zahadan University of Medical Sciences
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.ZAUMS.REC.1397.474
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Treatment adherence: The score of the research unit based on Ziaee's treatment adherence questionnaire and its scope is 0-100
Timepoint
Treatment adherence measurements one and three months after the intervention
Method of measurement
Treatment adherence questionnaire
2
Description
Re-admission: Re-admission patients within three months after discharge due to heart disease
Timepoint
Measurement of patients' re-admission three months after intervention
Method of measurement
By telephone with patients and registered in the relevant form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The content of the education will be provided by the Teach back method in three sessions individually and 24 hours after the patient's admission. At the first session about the disease, risk factors, symptoms, complications and the importance of preventing them, in the second session on nutrition،exercise And at the third session about the medications and the medication diet, the education will be provided.
Category
Lifestyle
2
Description
Control group: In the control group, routine care has been taken and there is no intervention.After studying patients' re-admission and adherence to treatment, will be examined.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital Zahedan
Full name of responsible person
Fariba Yaghoubi Nia
Street address
School Of Health, Zahedan University Of Medical Sciences, Jannat Blvd, Prof. Hesabi Sq, Zahedan, Iran. Zahedan Sistan And Baluchestan Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3329 5572
Fax
+98 54 3329 5572
Email
yaghoubinia@gmail.com
Web page address
http://zaums.ac.ir
2
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Fariba Yaghoubi Nia
Street address
Zahedan, Jam-e-jam Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 6269
Email
yaghoubinia@gmail.com
Web page address
http://zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nor Muhammad Bakhsani
Street address
University of Medical Sciences and Health Services, Zahedan University of Medical Sciences, Dr. Hesabi - Persian Gulf Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhsani@zaums.ac.ir
Web page address
http://zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubi Nia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Web page address
http://zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubi Nia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Web page address
http://zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fariba Yaghoubi Nia
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
yaghoubinia@gmail.com
Web page address
http://zaums.ac.ir
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
Yes - There is 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
The Main Outcomes of the Participants are Public.
When the data will become available and for how long
6 months after the results .
To whom data/document is available
Researchers at Academic and Academic Institutions .
Under which criteria data/document could be used
Statistical Result .
From where data/document is obtainable
Nursing and Midwifery Faculty of Zahedan Phone and Fax: 05433442481 Zip Code: 9816913396 Address: Faculty of Nursing and Midwifery, Zahedan, Zahedan Nursing and Midwifery Faculty, Fellowship Square
What processes are involved for a request to access data/document