Protocol summary

Study aim
Comparison of the effect of facial-facial and visual education on the quality of life of hemodialysis patients undergoing hemodialysis center in 17th Shahrivar Hospital and Waaham Hospital in Shahr-e-Mashhad
Design
In this study, 180 patients undergoing hemodialysis and studying conditions who were referred to dialysis centers of Ghaem Hospital and Wahefzah Shahrivar, Mashhad, were selected. The participants were randomly assigned to two groups of intervention and control and assigned to each participant a given code.
Settings and conduct
After determining the educational needs of hemodialysis patients in the field of diet, a self-care curriculum was developed by studying books and consulting with nutritionists in this area. The researchers developed and developed a booklet. The training was identical in both groups and was provided by the researcher. A video was used in various media. In the face-to-face training group, a 30- to 45-minute training session was conducted in person and weekly during dialysis, and was presented to the video training group within a week of dialysis. A questionnaire This interview was completed again at the end of the intervention. This study is a blind one-way study, in which the subjects of the company, the clinical caregiver, the data analyst, the safety committee of data monitoring, were not informed about the method of blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ages 65-18; minimum reading and writing literacy; kidney disease; end stage; permanently undergo hemodialysis; cognitive impairment; hearing loss; weekly two or three times each time Three to four hours undergoing dialysis; not seeing formal education about food during the intervention; at least 3 months and maximum 2 years being treated with dialysis; willing to participate in this study. Exclusion criteria: Cancellation of the study at any stage; Any event that prevents further intervention.
Intervention groups
Intervention group: Pre-test, by completing the demographic information journals, in face-to-face education group, 30-45 minute training sessions, performed individually and intervals of one week during dialysis, and were prepared in the video training group of the film. , Was displayed within one week during dialysis. The questionnaire was completed again at the end of the intervention by interview. Control group: The pre-test was completed through the completion of demographic information, diet, and knowledge on disease in this department. Did not take place and received the usual care.
Main outcome variables
Evaluation of patients' quality of life before and after intervention in intervention and control groups

General information

Reason for update
Acronym
H.E
IRCT registration information
IRCT registration number: IRCT20171013036747N2
Registration date: 2018-01-17, 1396/10/27
Registration timing: retrospective

Last update: 2018-01-17, 1396/10/27
Update count: 0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Rasool Solaimani Moghadam
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
rasool.solaimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
2016-01-21, 1394/11/01
Actual recruitment end date
2016-04-08, 1395/01/20
Trial completion date
empty
Scientific title
Comparison of the effect of face-to-face and visual education on the quality of life of patients undergoing hemodialysis
Public title
The effect of dietary education on the quality of life of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least reading and writing skills End-stage renal disease, which is consistently under hemodialysis treatment Not having cognitive impairment, hearing loss or hearing loss Two weeks three or three times a week for dialysis Not seeing formal education about food during the intervention At least 3 months and maximum 2 years treated with dialysis Would like to participate in this research.
Exclusion criteria:
Cancellation of the study at any stage Any incident that prevents further intervention. Patient death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 147
Actual sample size reached: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients; Clinical Clinical; Data Analyzer; Safety Data Supervisor; No data were available on how to blast the company.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691954865
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
GMU.REC.1393.34

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis

Primary outcomes

1

Description
Quality of Life
Timepoint
Before the intervention, one week after the intervention, face to face training
Method of measurement
SF36 quality of life questionnaire

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group 1: Face-to-face training group, 30- to 45-minute training sessions of dietetics, per person per week and weekly during dialysis. Intervention group 2: A video training group produced diet films, at intervals of one week Displayed during dialysis.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Qa'im Hospital
Full name of responsible person
Abolfazl Ghadimifar
Street address
Ghaem Hospital - Taghi Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir

2

Recruitment center
Name of recruitment center
Seventeen Shahrivar Hospital
Full name of responsible person
Abolfazl Ghadimifar
Street address
Couchesangi street
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٥٩٧٣٨٨٤
Phone
+98 51 5845 2271
Email
razavi@tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691954865
Phone
+98 51 5722 3028
Email
Dr.Mohammadpour@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Rasool Solaimani Moghadam
Position
Nursing non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691954865
Phone
+98 51 5722 3028
Email
rasool.solaimani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Rasool Solaimani Moghadam
Position
Nursing non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691954865
Phone
+98 51 5722 3028
Email
rasool.solaimani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Rasool Solaimani Moghadam
Position
Nursing non-faculty
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
9691954865
Phone
+98 51 5722 3028
Email
rasool.solaimani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
10 months after printing results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Just statistical tests
From where data/document is obtainable
To receive the data, they can only send their application to the email address of the person responsible for the study E-mail:rasool.solaimani@yahoo.com
What processes are involved for a request to access data/document
After reviewing the ethics code of the respective research committee and the approval date and the university identification certificate of the applicant
Comments
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