Determining the effect of healthy nutrition education through virtual social networking on quality of life in hemodialysis patients
Design
Clinical trials with control group, without placebo, single-centered, one-blind, randomized
Settings and conduct
The present study will be conducted at Hemodialysis Center in Saveh on hemodialysis patients. The analyzer will not know how to place the samples in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Reading, writing and communicating skills.
Access to smartphone, internet and Soroush messenger.
The willingness to collaborate in study and signing a informed consent form.
At least two dialysis sessions per week.
Absence of acute and chronic gastrointestinal ulcers.
18 to 65 years old.
Not attending other nutrition education classes.
Eclusion criteria:
Unwilling to participate in the study.
Intervention groups
Intervention group: samples of the intervention group will be trained in one-month-long course with healthy nutrition program in hemodialysis patients by creating a group channel in Soroush's messenger.
Control group: during this period, samples of control group will not receive any intervention.
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161223031522N8
Registration date:2018-10-01, 1397/07/09
Registration timing:retrospective
Last update:2018-10-01, 1397/07/09
Update count:0
Registration date
2018-10-01, 1397/07/09
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Healthy Nutrition Education through Virtual Social Network on Quality of Life in Hemodialysis Patients
Public title
The Effect of Healthy Nutrition Education through Virtual Social Network on Quality of Life in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Reading, writing and communicating skills.
Access to smartphone, internet and Soroush messenger
Desire to participate in the study and sign form of informed consent.
At least two dialysis sessions per week.
At least 3 months of dialysis history.
Lack of acute and chronic gastrointestinal ulcers.
18 to 65 years old.
Not attending other nutrition education classes.
Exclusion criteria:
Unwillingness to collaborate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected easily, then divided by random allocation method and randomly assigned to two groups of intervention and control, using table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The information analyzer will not know how to allocate the intervention and control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Near of Amir Kabir Hospital, Shahid Shiroodi Street, A'lam-Al-Hoda Street
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.ARAKMU.REC.1397.055
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for renal dialysis
Primary outcomes
1
Description
Quality of life
Timepoint
In the pre-test, the quality of life questionnaire is completed by samples of both groups. After two months in the post-test, the questionnaires will be completed by samples of both intervention and control groups.
Method of measurement
Standard Quality of Life Questionnaire for Kidney Patients (KDQOL-SF)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: samples of the intervention group will be trained in one-month-long course with healthy nutrition program in hemodialysis patients by creating a group channel in Soroush's messenger.
Category
Lifestyle
2
Description
Control group: during this period, samples of control group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Hamidreza Baradaran
Street address
Modarres hospital, Motahhari St., Azadi Sq.
City
Saveh
Province
Markazi
Postal code
3918698786
Phone
+98 86 4234 3395
Email
info@savehums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Near of Amir Kabir Hospital, Shahid Shiroodi Street, A'lam-Al-Hoda Street
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri Salahshour
Position
MSc of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared after unidentifiable of people.
When the data will become available and for how long
The beginning of the access period is 36 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Dr Mahboubeh Sajjadi, Ph.D. of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran.
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the requester, the information will be sent within 2 to 3 business days.