Protocol summary

Summary
The aim of this study is to improve health literacy in hemodialysis patients. inclusion criteria:;Get three dialysis sessions per week;One-year history of dialysis;Lack of mental disorders and diseases based wide area file;Being patient is pre-contemplation and contemplation based on a questionnaire in accordance with the framework Transtheoretical. Exclusion criteria:unwillingness to continue the study;Dialysis interrupted for any reason, including kidney transplantation. The study population of dialysis patients referred to hospitals but age is Borujen and Hajar. Of the patients on hemodialysis days of referral on the basis of the proposed formulas are divided into two groups of 33. Empowerment program based on the structures of TTM for seven 45-minute sessions will run for the intervention group and So after the intervention, one month, three months and six months later health literacy questionnaire will be completed by the researcher.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606112861N12
Registration date: 2016-07-29, 1395/05/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-29, 1395/05/08
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sharekord University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program based on the Trans Theoretical Model (TTM) on health literacy of peoples undergoing haemodialysis
Public title
The impact of the empowerment program on health literacy in hemodialysis patients
Purpose
Other
Inclusion/Exclusion criteria
inclusion criteria:Age over 18 years;ability to read and write;Get three dialysis sessions per week;One-year history of dialysis;Lack of mental disorders and diseases based wide area file;Lack of medical science-related college education;Maximum age 60 years;Being patient is pre-contemplation and contemplation based on a questionnaire in accordance with the framework Transtheoretical Exclusion criteria:unwillingness to continue the study;Dialysis interrupted for any reason, including kidney transplantation
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: 66
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
Shahrekord University of Medical Sciences
Street address
Kashani Bld. Shahrekord. IRAN
City
Shahrekord
Postal code
8815713471
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SKUMS.REC.1395.82

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis

Primary outcomes

1

Description
Health Literacy
Timepoint
Before the intervention, after intervention, one month, three months and six months later
Method of measurement
Health literacy questionnaire TOFHLA

Secondary outcomes

1

Description
no
Timepoint
no
Method of measurement
no

Intervention groups

1

Description
In the intervention group empowerment program based on meta-theory framework for 7 sessions of 45 minutes is performed.The control group doing routine
Category
Behavior

2

Description
The control group doing routine.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The Hajar Hospital ShahreKord
Full name of responsible person
Dr Reza Masoodi
Street address
The Hajar Hospital ShahreKord- Hemodialysis Department
City
ShareKord

2

Recruitment center
Name of recruitment center
Borujen Vali-Asr Hospital
Full name of responsible person
Dr Reza Masoodi
Street address
Borujen Vali-Asr Hospital Dialysis unit
City
Borujen

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sharekord University of Medical Sciences and Health Services
Full name of responsible person
Dr Kamal Solati
Street address
Shahrekord Kashani Blvd.
City
Sharekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sharekord University of Medical Sciences and Health Services
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
Sharekord University of Medical Sciences and Health Services
Full name of responsible person
Dr Reza Masoodi
Position
Assistant Professor Faculty
Other areas of specialty/work
Street address
Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Sharekord
Postal code
Phone
+98 38 1333 5653
Fax
Email
masoodi1383@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sharekord University of Medical Sciences and Health Services
Full name of responsible person
Dr Reza Masoodi
Position
Assistant Professor Faculty
Other areas of specialty/work
Street address
Nursing Department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
Phone
+98 38 1333 5653
Fax
Email
masoodi1383@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences Graduate Student
Full name of responsible person
Rahmat o Allah Kord Yazdi
Position
Graduate Student
Other areas of specialty/work
Street address
Nursing department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
Phone
Fax
Email
kordyazdi@gmail.com
Web page address

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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