Determining the effect of education on the quality of nutrition of hemodialysis patients in the prevalence of COVID-19.
Design
Clinical trial with intervention and control groups, with parallel groups, one-way blind, randomized, because the drug was not used in this study, the trial phase is not applicable in this study. About 60 patients. A random number table was used for randomization.
Settings and conduct
Field of study of Jiroft city of Kerman province. Study place Jiroft University of Medical Sciences. One-way blind patients are unaware of the division into intervention and control groups.
Participants/Inclusion and exclusion criteria
1- Willingness to participate in research
2. Have a minimum literacy
3. Access to the smartphone
Intervention groups
Participants are divided into two groups of 30 control and intervention. All of them will be encouraged to fast for 10 hours a day with a family member who has the necessary knowledge about using the Internet to attend the initial meeting and take a blood sample of albumin and TIBC serum in the hemodialysis ward of the hospital. Imam Khomeini (RA) to participate in Jiroft. In the intervention group, before and after the intervention, blood samples will be taken free of charge and according to laboratory standards, and their height and weight will be measured and body mass index will be calculated and recorded. The questionnaires are then completed by interview. Educational materials will be presented through cyberspace in the form of educational materials in the form of films, images, scientific texts, etc. in 10 sessions, as well as times for questions and answers and discussions. 3 months after the intervention, the data will be collected again by the same questionnaires. The control group will receive routine training and interventions as scheduled.
Main outcome variables
Quality of nutrition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210424051067N1
Registration date:2021-05-11, 1400/02/21
Registration timing:prospective
Last update:2021-05-11, 1400/02/21
Update count:0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Mahdiyeh Rafiei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4331 1686
Email address
m.rafiei@iauk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on the quality of nutrition of patients undergoing hemodialysis in the prevalence of COVID-19
Public title
The effect of education on the quality of nutrition of patients undergoing hemodialysis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Have a minimum literacy rate
Smartphone access
Exclusion criteria:
Creating unexpected conditions for the patient
Reluctance to continue participating in the study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients with random entry blocking criteria with 4 blocks will be identified using a random number table of Random Allocation Software. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. The sample allocation ratio will be 1: 1 and will be divided into intervention and control groups. Patients will then be instructed based on the blocks obtained and in the order of allocation sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a one-way blind randomized clinical trial. In this way, patients are divided into two groups by one of the researchers who do not interfere in the intervention and evaluation of results. The intervention group is labeled A and the control group is labeled B. Using a table of random numbers, participants are randomly divided into groups A and B in blocks of four [ABAB, BAAB, etc. ]. The data analyst does not know in which group each participant was divided. Before dividing, all participants are told that dividing them into groups will not harm them, and they will be informed in order to be divided into groups. The experimental group receives educational intervention and the control group receives routine care and training.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Azad University of Kerman
Street address
Azad University of Kerman, Valiasr Blv., Kerman
City
Kerman
Province
Kerman
Postal code
۷۶۳۵۱۳۱۱۶۷
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.IAU.KERMAN.REC.1399.012
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Quality of nutrition
Timepoint
Before the intervention and three months after
Method of measurement
questionnaire - Blood test (TIBC-Alb)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in this study is a group of 30 people, all of whom will be emphasized to participate in the initial session with 10 hours of fasting per day with a family member who has the necessary knowledge about using the Internet. And take a blood sample of albumin and serum TIBC in the hemodialysis ward of Imam Khomeini Hospital in Jiroft. Before and after the intervention, blood samples will be taken for free and according to laboratory standards and their height and weight will be measured and body mass index will be calculated and recorded. The questionnaires are then completed by interview. Educational materials will be presented through cyberspace in the form of educational materials in the form of films, images, scientific texts, etc. in 10 sessions, as well as times for questions and answers and discussions. 3 months after the intervention, the data will be collected again by the same questionnaires.
Category
N/A
2
Description
Control group: The control group in this study is a group of 30 people who receive routine training and interventions according to the previous schedule.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mahdiyeh Rafiei
Street address
Shafa St., Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
78611764787
Phone
+98 34 4331 6313
Email
rafiei.2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Kazemipour
Street address
Azad University of Kerman, Valiasr Blv., Kerman town
City
kerman
Province
Kerman
Postal code
۷۶۳۵۱۳۱۱۶۷
Phone
+98 34 3321 0043
Fax
+98 34 3321 0051
Email
ertebat@iauk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Jeeroft University of Medical Sciences
Full name of responsible person
Mahdiyeh Rafiei
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shafa St., Imam Khomeini Hospital
City
Jiroft
Province
Kerman
Postal code
78611764787
Phone
+98 34 4331 6313
Email
rafiei.2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Khandan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University of Kerman , Valiasr Blvd.
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 4331 1686
Email
mkhandan@iauk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mahdiyeh Rafiei
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Resalat St., No. 114
City
Jiroft
Province
Kerman
Postal code
7861765119
Phone
+98 34 4331 1686
Email
rafiei.2001@yahoo.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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some data, such as main outcome information and demographic information, can be shared after making individuals unrecognizable.
When the data will become available and for how long
The start of access to information is 36 months after the results are published.
To whom data/document is available
Researchers working in academic, scientific and industrial institutions.
Under which criteria data/document could be used
In order to be used for scientific purposes and by mentioning the source used.
From where data/document is obtainable
Dr Maryam Khandan, PHD in Nursing, Islamic Azad University Kerman Branch, Iran
Email address: M_khandan49@yahoo.com
What processes are involved for a request to access data/document
After receiving the email from the applicant, the information will be sent within 3 to 5 working days.