Determining the effect of educational program based on planned behavior pattern on the improvement of lifestyle in hemodialysis patients
Design
Randomized clinical trial with control group. Sample size: 112
Settings and conduct
The place of the study will be Ahvaz Golestan and Imam Khomein educational hospitals affiliated to Jundishapur University of Medical Sciences. The stages of the study are: Performing pre-test and then statistical analysis; Training based on the results of the analysis and then doing post-test one month and three months after the intervention
Participants/Inclusion and exclusion criteria
Inclusion criterion: age over 18 years old; History of dialysis; Not having physical and mental illness; Ability to communicate, read and write; attending training sessions. Non inclusion criteria: Complications during dialysis and the need for medical measures; Moving to special wards.
Intervention groups
The samples were randomly divided into intervention and control groups; the intervention group received training, but the control group did not receive any training.
The effect of educational program based on the planned behavior pattern on improving lifestyle in hemodialysis patients
Public title
Assessment of hemodialysis patients lifestyle
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Being at least 3 months under hemodialysis
The absence of any disabling physical or psychological illness that overwhelms the ability to participate in the study
Ability to communicate
Ability to read and write
Ability to attend classes
Exclusion criteria:
Complications during dialysis and the need for medical measures
Moving to special wards
Being illiterate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to the intervention and control groups was done by permutation blocks method which was done by statistician
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-19, 1397/07/27
Ethics committee reference number
IR.AJUMS.REC.1397.531
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
Life style
Timepoint
Before the intervention, 1 month and 3 months after the intervention
Method of measurement
Lifestyle standard questionnaire
Secondary outcomes
1
Description
Intent to behave
Timepoint
Before the intervention, 1 and 3 months after the intervention
Method of measurement
Questionnaire
2
Description
Attitude towards behavior
Timepoint
Before the intervention, 1 and 3 months after the intervention
Method of measurement
Questionnaire
3
Description
Mental norms
Timepoint
Before the intervention, 1 and 3 months after the intervention
Method of measurement
Questionnaire
4
Description
Perceived behavioral control
Timepoint
Before the intervention, 1 and 3 months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: education; Teaching method using Face-to-Face education and educational materials is provided as a booklet and pamphlet (tutorials on renal transplantation; kidney function; hemodialysis; fluid intake; dietitian in hemodialysis patients; catheter care, fistula and graft care As well as self-care); the number of sessions is 4 which will be held during 4 weeks and each session lasts one hour.
Category
Behavior
2
Description
Control group: A pre-test. No training will be deliverd. A booklet and a pamphlet will be provided to them. A month and three months later, a questionnaire is also provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Mahin Ghibibzadeh
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
GolestanjPsPital@yahoo.com
2
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Mahin Ghibibzadeh
Street address
Azadegan Avenue
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
fnursing-ahvaz@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Ghibibzadeh
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8394
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahin Ghibibzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Faculty, Ahvaz University of Medical Sciences, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8394
Email
Gheibizadeh-m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Jafari Nahl Ashkanani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Faculty, Ahvaz University of Medical Sciences, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
jafarinahlashkanani.f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Jafari Nahl Ashkanani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing Midwifery Faculty, Kargar township, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8331
Email
jafarinahlashkanani.f@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data on the primary and the secondary outcomes can be shared.
When the data will become available and for how long
Starting the access period 6 months after printing the results
To whom data/document is available
Data is only available to researchers working at universities.
Under which criteria data/document could be used
It can be used to evaluate patients' behavior change programs.
From where data/document is obtainable
The data is available in the archives of theses of the Faculty of Nursing and Midwifery affiliated to Ahvaz University of Medical Sciences; email: school_nm@ajums.ac.ir.
What processes are involved for a request to access data/document
First, you must apply to Ahvaz University of Medical Sciences; After examining the request by the Vice-Chancellor, the application is sent to the Nursing Midwifery Faculty, and is sent to the Nursing School of Nursing and Midwifery Library to provide data.