Determining the effect of virtual training on arteriovenous fistula maturation in hemodialysis patients
Design
A clinical trial with a test and control group will be conducted on 50 patients in a randomized method using four permutation blocks.
Settings and conduct
Research location: Dialysis Center of Mashhad Province Hospital. The samples are divided into two groups.The intervention group (virtual training through WhatsApp) and the control group (routine training) which are selected through a lottery.
Participants/Inclusion and exclusion criteria
Entry requirements: consent to participate in the study; reading and writing literacy in the Persian language; having a smartphone and installing WhatsApp; absence of cognitive and mental problems; patients with a fistula preparation, and the first access to hemodialysis. Exit conditions: unwillingness to continue cooperation in the study; patient migration; failure to participate in training sessions for more than two weeks; presence of rupture or hematoma in the vascular access path.
Intervention groups
Before starting the intervention, The people in the test and control group completed questionnaires related to demographic information and hemodialysis-related information and a vascular access checklist in virtual form. And The vascular condition of the patients will be checked. After completing the questionnaires, The researcher will conduct his training for the people of the test group within 6 weeks
Main outcome variables
Duration of fistula implantation; Arteriovenous fistula anastomosis type; Vascular status of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231011059695N1
Registration date:2024-07-13, 1403/04/23
Registration timing:prospective
Last update:2024-07-13, 1403/04/23
Update count:0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Fateme Ghodsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3657 8193
Email address
ghodsif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual training on arteriovenous fistula preparation in hemodialysis patients
Public title
The effect of virtual training on arteriovenous fistula preparation in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Reading and writing literacy in Persian language
Having a smartphone and installing WhatsApp
Absence of cognitive and mental problems
Patients who have a fistula preparation and the first access is hemodialysis (not re-repaired)
Exclusion criteria:
Unwillingness to continue cooperation in the study
Patient migration
Failure to participate in training sessions for more than two weeks
Presence of rupture or hematoma in the vascular access path
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were first selected by the available sampling method and then randomly using blocks of four permutations in one of the two intervention groups (virtual training via WhatsApp) And Control (routine training) were placed. So that the list of 6 expected blocks (AABB, ABAB, BABA, ABBA, BAAB, BBAA) was Prepared and assigned a number to each block (from 1 to 6) Blocks are randomly selected by throwing dice Necessary allocation was made (A for the test group and B for the control 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 Gonabad University of Medical Sciences
Street address
Central Headquarters, Gonabad University of Medical Sciences, Imam Khomeini Street, Ghadir Square
Duration of fistula implantation, Anastomosis type of arteriovenous fistula
Timepoint
6 weeks of training in ways to care for vascular accesses through the WhatsApp social networkTo prepare arteriovenous fistula In patients undergoing hemodialysis
Method of measurement
Questionnaire of demographic information and information related to hemodialysis and vascular access check list
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, training in the form of educational clips, photos, text or audio files on WhatsApp weekly for 6 weeks including: information and care tips about the disease, causes and risk factors; the correct time to see a doctor at a specified time; The basis of fistula operation, the advantages and disadvantages and complications of fistula, how to take care of the vascular access of fistula and artificial vessel so that it does not fail; The underlying diseases that are involved in the failure of vascular access include diabetes, blood pressure, and the use of effective drugs to control it; physical activity, training of vascular highlighting exercises; Nutrition and stress management will be given to patients.
Category
Prevention
2
Description
The control group will receive the usual training of the dialysis center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Fatemeh Ghodsi
Street address
Next Akbar Hospital, Kaveh Blvd., Fekori Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 915 302 9134
Email
ghodsif1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Musa Sajjadi
Street address
Ghadir Square, Imam Khomeini Street, Gonad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 915 533 6294
Email
Sajjadi1975@gmail.com
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
Fatemeh Ghodsi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 930 529 9742
Email
ghodsif1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ghodsi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Ghadir Square
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 930 529 9742
Email
ghodsif1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Fatemeh Ghodsi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical Sciences, Imam Khomeini Street, Ghadir Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 930 529 9742
Email
ghodsif1@mums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available