Protocol summary

Summary
This study aimed to evaluate the Effect of education with teach–back educational method on self-care among renal transplant recipients. In this randomized clinical trial study, 80 kidney transplant patients will be selected from the clinics of Imam khomeini Hospital in Urmia in 2016 and patients will be randomly assigned to two groups including intervention and control groups, using sealed envelope technique. Then in the intervention group educational content will be taught with teach–back educational method in five 60 minute session. The control group will receive routine care in the clinic. Teach back educational method provides a dynamic and bilateral Learning. First, the educator presents the contents relating to self-care, then the patient will repeat the learnt contents and this process continues between patient and educator until full understanding of the content. Self-care factors will be presented in five aspects, including Self-monitoring, Self-care behavior in daily living, early detection and coping with abnormalities after kidney transplantation, Stress management and uncategorized factors. Patients who have desire and sufficient literacy and have not a mental or infectious diseases will be enrolled in the study and patients who have previously participated in educating classes will be excluded. Data will be collected by demographic questionnaire and a special questionnaire on self-care in kidney transplant recipients and will be measured and compared through pre-test and post-test.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016122817059N10
Registration date: 2017-02-16, 1395/11/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-02-16, 1395/11/28
Registrant information
Name
Masoume Hemmati Maslakpak
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1365 9031
Email address
hemmati_m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education with teach–back method on self-care among renal transplant recipients
Public title
Effect of education with teach–back method on self-care among renal transplant recipients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: signing the consent form; being at the age of 18-60 years; having the ability to read and write; willingness to participate in educational classes, complete the questionnaire ; absence of any mental disorders according to patients’ records; Passing at least three months and a maximum of 12 months from the kidney transplantation; absence of debilitating or infectious disease; Ability to establish telephone contact with the patients; having records at the renal transplant clinic of Urmia; Exclusion criteria: Lack of consent to participate in the study; participation in other classes and educational programs about kidney transplantation and postoperative care of the patients during the study; having a limitative condition or disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
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 Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Jahad square, Urmia
City
Urmia
Postal code
575611-5111
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.umsu.rec.1395.236

Health conditions studied

1

Description of health condition studied
Renal Transplant
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Self-Care
Timepoint
Before the intervention; two months after the intervention
Method of measurement
Questionnaire of self-care in kidney transplant

Secondary outcomes

1

Description
Self-esteem
Timepoint
Before the intervention; two months after the intervention
Method of measurement
ROSENBERG Self-esteem scale

Intervention groups

1

Description
control group: The control group will receive routine care of clinic.
Category
Other

2

Description
Intervention group: educational content will be taught individually with teach–back educational method in the form of Face to face through five 60 minute sessions. Self-care education will be presented in five aspects, including Self-monitoring, Self-care behavior in daily living, early detection and coping with abnormalities after kidney transplantation, Stress management and uncategorized aspect.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Renal Transplant Clinic in Imam khomeini Hospital in Urmia
Full name of responsible person
Farzin Mollazadeh
Street address
Renal transplant clinic, Imam Khomeini Hospital, Ershad Ave, Modarres Blvd, Urmia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia University of Medical Sciences, Jahad square, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Masoomeh Hemmati Maslak Pak
Position
Associate Professor, educational Deputy of Urmia Nursing and Midwifery faculty
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Nazloo, Urmia
City
Urmia
Postal code
5756115111
Phone
+98 44 3275 4961
Fax
Email
hemmatma@yahoo.com
Web page address
www.nm.umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Urmia Nursing and Midwifery faculty
Full name of responsible person
Farzin Mollazadeh
Position
Student of Master of Science in Medical and Surgical Nursing
Other areas of specialty/work
Street address
Urmia Nursing and Midwifery faculty, Nazloo, Urmia
City
Urmia
Postal code
Phone
+98 914 347 9187
Fax
Email
farzin.nurse@gmail.com
Web page address
www.nm.umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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