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Effect of an educational program based on Teach-Back method on adherence to treatment regimen in patients with end stage renal disease.

Protocol summary

Summary
The aim of this clinical trial was to determine the effect of using teach-back education on the treatment adherence of patients with end stage renal failure. In this randomized clinical trial, 90 patients with end stage renal Disease and undergoing hemodialysis who referred to Sina Hospital , Tehran at 2016 were divided into two groups. In the intervention group, in addition to routine training, teach-back method education in four dimensions of hemodialysis, medication, fluid intake and diet, for 45 min was performed. In the control group, training was only as routine training .Treatment adherence were evaluated in 3 steps including pre-test, post-test (7 days after the intervention), and fallow-up (30 days after the intervention), by using end stage renal disease adherence questionnaire. Age, sex, educational level and duration of hemodialysis in both groups were identified.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017050824277N2
Registration date: 2017-06-08, 1396/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-08, 1396/03/18
Registrant information
Name
Mehdi Pakbaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 7096
Email address
ma.pakbaz@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-05-22, 1395/03/02
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of an educational program based on Teach-Back method on adherence to treatment regimen in patients with end stage renal disease.
Public title
Effect of an educational program based on Teach-Back method on adherence to treatment regimen in patients with end stage renal disease.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The definitive diagnosis of kidney disease and hemodialysis patient ؛ Age over 18 years ؛ tendency to participate in the study ability to reading and writing ؛ Non-acute disease or acute kidney failure ؛ No other chronic diseases such as stroke, myocardial infarction and malignant tumors ؛ lack of cognitive impairment, speech and hearing Exclusion criteria : unwillingness to continue to cooperate in the study ؛ cognitive impairment, speech and hearing ؛ feet or transfer the patient to a medical facility
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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 University Of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave، Daneshjo Blvd،Evin
City
Tehran
Postal code
1985713834
Approval date
2017-02-04, 1395/11/16
Ethics committee reference number
IR.USWR.REC.1395.290

Health conditions studied

1

Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic Kidney Disease, stage 5

Primary outcomes

1

Description
treatment adherence of patients with end stage renal failure (ESRD).
Timepoint
Before the study, 7 days after of the study, 30 days after of study
Method of measurement
With the End Stage renal Disease Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Teach-Back education method
Category
Prevention

2

Description
control group : Routine Educations
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mrs. Babae
Street address
Hasan Abad Squar
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Akbar Ghanbari
Street address
Kodakyar Ave، Daneshjo Blvd،Evin
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Akbar Ghanbari
Position
Student
Other areas of specialty/work
Street address
Kodakyar Ave ، Daneshjo Blvd، Evin
City
Tehran
Postal code
1985713834
Phone
+98 2102122180098
Fax
+98 51 4622 5334
Email
AKBARGHANBARI44@YAHOO.COM
Web page address
http://www.uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University Of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Kian Nouruzi Tabrizi
Position
Associate Professor
Other areas of specialty/work
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
TEHRAN
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
Email
dr.kian_nouroze@yahoo.com
Web page address
http://en.uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University Of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Akbar Ghanbari
Position
Student
Other areas of specialty/work
Street address
Kodakyar Ave، daneshjo Blvd، Evin
City
TEHRAN
Postal code
1985713834
Phone
+98 21 3616 0746
Fax
Email
AKBARGHANBARI44@YAHOO.COM
Web page address
AKBARGHANBARI44@YAHOO.COM

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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