Protocol summary

Study aim
Determining the effect of training program based on the barriers, on knowledge, attitude and Intention to do peritoneal dialysis in patients with end-stage renal disease
Design
this is a community based nonrandomized clinical trail with no control group carried out on 45 patients who had the indication for peritoneal dialysis without any blinding.
Settings and conduct
in a quasi-experimental study without the control group with pretest-post test, 45 ESRD patients with peritoneal dialysis indication were selected with purposeful sampling.their knowledge and attitude were evaluated by a questionnaire. The training program was presented to them individually in one 60-75 min session.For some of the patients the training program was presented in two sessions according to their physical or hemodialysis condition .
Participants/Inclusion and exclusion criteria
"Inclusion criteria:"tendency to participate in program, the age at least 18 years old, having indications for peritoneal dialysis. treatment of hemodialysis at least for 3 months, no severe cognitive disorder , no serious visual and hearing impairment. "Exclusion criteria:" unwillingness to participate.
Intervention groups
For intervention group, one training session (60-75 minutes) was held for getting awareness about peritoneal dialysis equipment (catheter, set and peritoneal dialysis fluid),the procedure and its advantages .For some of the patients the training was presented in two sessions according to their physical or hemodialysis conditions . Beside the training session, educational videos and pamphlet were given to the patients.
Main outcome variables
patients’ knowledge, patients' attitude , patients' Intention to do the peritoneal dialysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180826040873N1
Registration date: 2019-05-03, 1398/02/13
Registration timing: retrospective

Last update: 2019-05-03, 1398/02/13
Update count: 0
Registration date
2019-05-03, 1398/02/13
Registrant information
Name
Maliheh Salehi Kahrizsangi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3566 3371
Email address
malih.salehi1983@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
2018-09-11, 1397/06/20
Scientific title
The effect of educational program based on the barriers, on knowledge, attitude and Intention to do peritoneal dialysis in patients with end-stage renal disease
Public title
Effect of training on peritoneal dialysis acceptance
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having tendency to participate in training program Being in age range: 18 to 55 Having indications for peritoneal dialysis according to doctor’ diagnosis. Being treated as hemodialysis at least for three months. Having no severe cognitive impairment such as Alsheimer and Delirium . Having ability to read and write ( literacy ). Having no severe vision and hearing impairment that interfere with the training.
Exclusion criteria:
unwillingness to participate to study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Aboozar Avenue، Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159-81151
Approval date
2017-06-13, 1396/03/23
Ethics committee reference number
IR.KAUMS.REC.1396.33

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
Score of peritoneal dialysis knowledge test
Timepoint
Before intervention and seven days after training intervention
Method of measurement
The questionnaire of peritoneal dialysis knowledge

2

Description
The score of attitude toward peritoneal dialysis questionnaire.
Timepoint
Before intervention and seven days after training intervention
Method of measurement
The questionnaire of peritoneal dialysis attitude

3

Description
Intention to do the peritoneal dialysis
Timepoint
Before intervention and seven days after training
Method of measurement
asking the patient about the intention to do the peritoneal dialysis

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group (without any control group). The training program was presented individually for 60-75 minutes. for some of the patients the training program was presented in two sessions according to their physical condition or their hemodialysis condition. the training was presented in order to get awareness about peritoneal dialysis equipment such as catheter, set and peritoneal dialysis fluid along with its procedure and its advantages as well as providing videos and educational pamphlet
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhavan Hospital of Kashan
Full name of responsible person
Maliheh Salehi
Street address
No. 5, Sonbol Deadend, Shahid Abdollahi Alley, Emam Boulevard
City
Kooshk
Province
Isfehan
Postal code
8434136388
Phone
+98 31 3356 3371
Email
malih.salehi1983@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Kashan Medical Scineces University, Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5554 4299
Fax
+98 31 5557 5057
Email
banafshe-h@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mansoor Dianati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing college، Kashan university of medical sciences, Ghotb Ravandi Blvd,
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5554 0021
Email
mandianati@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maliheh Salehi
Position
M.A Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Sonbol Deadway, Shahid Abdollahi Alley- Emam Square
City
Kooshk
Province
Isfehan
Postal code
8434136388
Phone
+98 31 3356 3371
Email
malih.salehi1983@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maliheh Salehi
Position
M.A Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Sonbol Deadway, Shahid Abdolahi Alley- Emam Blvd.
City
Kooshk
Province
Isfehan
Postal code
8434136388
Phone
+98 31 3356 3371
Email
malih.salehi1983@gmail.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All information
When the data will become available and for how long
From January 1397
To whom data/document is available
All the researchers
Under which criteria data/document could be used
- Being the nursing student - Practitioner in dialysis unit
From where data/document is obtainable
Nursing college، Kashan university of medical sciences
What processes are involved for a request to access data/document
Request by email- responding after sending request during one month.
Comments
Loading...