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The effect of therapeutic educational program on behaviors and attitude toward therapeutic adherence and laboratory parameters of hemodialysis patients

Protocol summary

Study aim
The purpose of this study is to determine the demographic information, to determine the mean score of attitude toward adherence to the regimen, to determine the mean score of attitude toward adherence to the regimen, to determine the mean score of biochemical and hematological values of patients, comparison of the mean score of attitude toward compliance with the treatment regimen, comparison of the mean score of behaviors of treatment regimen and the comparison of the mean values of biochemical and hematological laboratory values before, one and three months after the intervention, between the control and experimental groups in hemodialysis patients referring to Imam Reza hospital in Sirjan in 1395.
Design
In this study, 60 patients undergoing hemodialysis in Imam Reza hospital of Sirjan who were eligible to enter the study were selected. Participants were randomly divided into two groups of study and control groups by Coupled and odd days of the week.
Settings and conduct
In this study, after obtaining the code of ethics and oral satisfaction from patients undergoing hemodialysis in Imam Reza Sirjan Hospital to participate in the study, two groups of intervention and control completed the questionnaires. Data were collected through two researcher-made questionnaires, which were prepared using two questionnaires of Renal Adherence Attitude Questionnaire and Renal Adherence Behavior Questionnaire. Laboratory values were also performed with the coordination of the hospital and a specific kit. In the first stage of the intervention, after the assessment of the educational needs, the educational program was designed in the intervention group and given 3 sessions per week, face-to-face and individual. In the control group, regular education was given.Then, in both groups, the questionnaires were completed again one month and three months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criterias are: Over age 14 years, hemodialysis for at least 6 months, hemodialysis 3 times per week and 3-4 times per week, and non-inclusion criteria are: renal transplant candidate, reluctance to continue participating the Study, being in the uremic phase of the disease and developing mental illness that prevents the patient from being properly contacted
Intervention groups
In this study, the study groups included the intervention group and the control group. The intervention group received an educational written program in face-to-face and individual sessions at intervals of one week for 3 sessions. The control group received routine training. Questionnaires were completed in both groups before, one month and three months later.
Main outcome variables
Attitude toward adherence to the regimen; attitude toward adherence to the regimen; laboratory parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170116031972N3
Registration date: 2018-01-14, 1396/10/24
Registration timing: retrospective

Last update: 2018-01-14, 1396/10/24
Update count: 0
Registration date
2018-01-14, 1396/10/24
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-25, 1395/10/05
Expected recruitment end date
2017-05-17, 1396/02/27
Actual recruitment start date
2016-12-25, 1395/10/05
Actual recruitment end date
2017-05-17, 1396/02/27
Trial completion date
empty
Scientific title
The effect of therapeutic educational program on behaviors and attitude toward therapeutic adherence and laboratory parameters of hemodialysis patients
Public title
The effect of educational program on the attitude and compliance of the treatment regime in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range over 14 years Being at least 6 months under hemodialysis Hemodialysis 3 times a week and every 3-4 hours
Exclusion criteria:
Candid for kidney transplant Unwilling to continue participating in the study Being in the Uremic phase of the disease Having mental disease (self-reported) that prevents the patient from being properly contacted
Age
From 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 69
Actual sample size reached: 60
Randomization (investigator's opinion)
Not 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 Kerman University of Medical Sciences
Street address
Ebnesina St،Jahad Blvd، Somaye Crossroad، Kerman
City
Kerman
Province
Kerman
Postal code
7815789957
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.KMU.REC.1395.164

Health conditions studied

1

Description of health condition studied
Chronic Renal Failure
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)

2

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis

Primary outcomes

1

Description
Attitude toward adherence to treatment regimen
Timepoint
Before intervention, one month and three month after intervention
Method of measurement
By filling the questionnaire

2

Description
Behaviors of the treatment regimen
Timepoint
Before intervention, one month and three month after intervention
Method of measurement
By filling the questionnaire

3

Description
laboratory parameters
Timepoint
Before intervention, one month and three month after intervention
Method of measurement
By measuring the levels of blood hematology and biochemistry

4

Description
Adequacy of dialysis
Timepoint
Before intervention, one month and three month after intervention
Method of measurement
Using Kt/V and URR test to measure dialysis adequacy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: face to face and individual educational program that provided.
Category
Behavior

2

Description
Control group: No intervention in control group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Emamm Reza Hospital of Sirjan, Dialysis Department
Full name of responsible person
Mohaddeseh Seteyesh
Street address
Hejrat blvd
City
Sirjan
Province
Kerman
Postal code
7815789957
Phone
+98 34 4234 0302
Email
setayesh.89.m@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ansari
Street address
Ebnesina St،Jahad Blvd، Somaye Crossroad، Kerman
City
kerman
Province
Kerman
Postal code
7815789957
Phone
+98 34 3252 6750
Email
setayesh.89.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research of Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohaddeseh Setayesh
Position
M.S of Medical Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, Haft Baghe Alavi
City
Kerman
Province
Kerman
Postal code
7815789957
Phone
+98 34 4233 1947
Email
setayesh.89.m@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi School, Haft Baghe Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7617949546
Phone
+98 34331325219
Email
Forozy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohaddeseh Setayesh
Position
Student Master of Medical Surgical
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Razi School of Nursing and Midwifery, Haft Baghe Alavi،
City
Kerman
Province
Kerman
Postal code
7815789957
Phone
+98 34 4233 1947
Email
setayesh.89.m@gmail.com

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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data can be shared after identifying individuals that are relevant to their original outcome.
When the data will become available and for how long
Starting the access period is 6 months after printing the results
To whom data/document is available
Access will only be available to scholars working in academic and academic institutions.
Under which criteria data/document could be used
The only analyzes used in the study are allowed for delivered data.
From where data/document is obtainable
Mohaddeseh Setayesh: setayesh.89.m@gmail.com
What processes are involved for a request to access data/document
When requesting the data, contact the e-mail address and the relevant application, along with the email, and the reason for the request and call number.
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