Comparison of effectiveness and non-effectiveness of peer-led education with family-based education on sleep quality in patients undergoing hemodialysis
comparative investigation of effectiveness of peer-led education with family-based education on sleep quality in patients undergoing hemodialysis
Design
In this study, 90 patients undergoing hemodialysis treatment, Who are eligible to enter the study, will be selected randomly and divided into three groups (two intervention and one control group).To hide the intervention group, each participant will be assigned a code.
Settings and conduct
This study will be conducted at Imam Reza hospital in Kermanshah. First, the conditions for entering the study will be explained for the patient clearly and, if desired, the informed consent form will be completed.This study will be done as not blinded study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:No history of participating in training programs related to lifestyle and adaptation methods during the last 6 months.No speaking or hearing impairment
Exclusion criteria: No participation in training courses for more than one session
Intervention groups
In the family-based intervention group, patient accompanied will receive 60 minutes training each session, three days a week (sunday - tuesday - thursday). Then, in collaboration with the patient accompanied , training sessions will be held for intervention groups in 5 sessions of 60 minutes.
In the peer-led group, 4 patients will be selected as the peer group leader.The peer group is divided into four groups, and each of these four individuals is randomly assigned to a group of eight people.Then, with the collaboration of the peer group, the training sessions will be held for intervention groups in 5 sessions of 60 minutes.
The control group will not receive any interventions
Main outcome variables
Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N85
Registration date:2018-02-11, 1396/11/22
Registration timing:registered_while_recruiting
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-04-04, 1397/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness and non-effectiveness of peer-led education with family-based education on sleep quality in patients undergoing hemodialysis
Public title
Investigation the effectiveness of peer-led education with family-based education on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of participating in training programs related to lifestyle and adaptation methods during the last 6 months
No speech impairment or hearing impairment
Catching other acute or chronic physical or mental disorders (such as cardiovascular, respiratory, musculoskeletal, liver or psychiatric disorders)
Exclusion criteria:
Non-participation in training courses for more than one session
Use of sleep medications during the study
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method will be used to implement random assignment.In this way, 90 consecutive (from 1 to 90) will written individually on a paper and will be placed in a container.Then, each of the participants in the trial is asked to randomly select one of these 90 numbers in the container containing the numbers.Individuals who have selected numbers from 1 to 30 will be assigned to group A ("control group") and those who have chosen numbers 31 to 60 to group B ("peer-led education group ") and those who have selected numbers 61 to 90 to group C ("family-based education Group")
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-10-24, 1396/08/02
Ethics committee reference number
ir.kums.rec.1396.392
Health conditions studied
1
Description of health condition studied
Hemodialysis - Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Sleep quality
Timepoint
The beginning and end of the study
Method of measurement
Based on the Pittsburgh Sleep Quality Questionnaire (PSOI)
Secondary outcomes
empty
Intervention groups
1
Description
In the family-based intervention group, patient accompanied will receive 60 minutes training each session, three days a week (sunday - tuesday - thursday). Then, in collaboration with the patient accompanied , training sessions will be held for intervention groups in 5 sessions of 60 minutes.
Category
Treatment - Other
2
Description
In the peer-led group, 4 patients will be selected as the peer group leader.The peer group is divided into four groups, and each of these four individuals is randomly assigned to a group of eight people.Then, with the collaboration of the peer group, the training sessions will be held for intervention groups in 5 sessions of 60 minutes.
Category
Treatment - Other
3
Description
The control group will not receive any interventions
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Mardanpour
Street address
Imam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mardanpour.m@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Mardanpour
Position
Maryam Mardanpour
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yesarat Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
mardanpour.m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Aliakbar Veisiraygan
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
visi_akbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Mardanpour
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
mardanpour.m@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
The main outcomes of the study will be shared.
When the data will become available and for how long
3months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail