The effect of evidence-based foot care training on self-efficacy and foot self-care behaviors in patients with diabetic foot ulcers
Design
This is a randomized clinical trial with a control group and a parallel design. This non-blinded, randomized study, will be performed on 62 patients with diabetic foot ulcers. A simple random method is used for randomization and the participants are assigned to two intervention and control groups.
Settings and conduct
This study, which will be conducted at Shahid Noorani Hospital in Talesh city, is non- blinded. All patients will receive routine hospital treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Diagnosis of diabetes
Age between 18 and 65 years; Patients with an active diabetic foot ulcer that does not require amputation based on the doctor's diagnosis; Ability to communicate
Exclusion criteria: A history of severe physical and mental illness; Receive any written instruction before starting the study
Intervention groups
In addition to routine hospital treatment, the intervention group will receive evidence-based nursing care training. The control group will only receive routine hospital treatment.
Main outcome variables
Self-efficacy, self-care behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N204
Registration date:2023-07-19, 1402/04/28
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
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
2023-07-01, 1402/04/10
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of evidence-based foot care training on self-efficacy and foot self-care behaviors in patients with diabetic foot ulcers
Public title
The effect of foot care training on self-efficacy and foot self-care behaviors in patients with diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Diagnosis of diabetes
Age between 18 and 65 years
Patients with an active diabetic foot ulcer that does not require amputation based on the doctor's diagnosis
Ability to communicate
Exclusion criteria:
A history of severe physical and mental illness
Receive any written instruction before starting the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 31 cards that are selected first are placed in the intervention group, and the remaining 31 in 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 Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.148
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
L97
ICD-10 code description
Non-pressure chronic ulcer of lower limb, not elsewhere classified
Primary outcomes
1
Description
self-efficacy
Timepoint
The beginning of the study and the end of the study
Method of measurement
Base on diabetic foot care self efficacy scale (DFCSES)
2
Description
Self-care bahavior
Timepoint
The beginning of the study and the end of the study
Method of measurement
Base on diabetes foot self-care bahavior scale (DFSBS)
Secondary outcomes
empty
Intervention groups
1
Description
In addition to routine hospital treatment, the intervention group will receive evidence-based nursing care training.
Category
Treatment - Other
2
Description
The control group will only receive routine hospital treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Nurai Hospital
Full name of responsible person
Dr. Marziyeh Ziaeirad
Street address
Talash road towards Rasht, next to the workers' stadium
City
Gilan
Province
Guilan
Postal code
5698452145
Phone
+98 13 4422 1102
Email
m.ziaeirad@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.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, Khorasgan branch
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
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Marziyeh Ziaeirad
Position
Member of the faculty of Khorasan Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.ziaeirad@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Marziyeh Ziaeirad
Position
Member of the faculty of Khorasan Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.ziaeirad@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Marziyeh Ziaeirad
Position
Member of the faculty of Khorasan Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.ziaeirad@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD