Investigating the Effect of Self-Care Educational Program Based on the BASNEF Model on Diabetic Foot Ulcer Care in Patients Referring to Shahid Shabani Nejad Diabetes Clinic in 2024
Determining the effectiveness of the self-care training program based on the BASNEF model for the care of foot ulcers of patients with diabetes referring to Shahid Shabani Nejad Diabetes Clinic in 2024
Design
This study is a clinical trial with a control group, with parallel groups, blinded and randomized, which will be conducted on 120 patients.
Settings and conduct
The research environment is Shahid Shabaninejad Diabetes Clinic in Isfahan city. Each of the participants will be assigned a unique identification number, and then using the randomization sequence, they will be randomly assigned to two intervention or control groups. Participants will be unaware of study group allocation.
Participants/Inclusion and exclusion criteria
1. Consent to participate in research
2. Diagnosis of type 2 diabetes by an endocrinologist
3. Having a diabetic foot ulcer of grade 1 to 3 by the Wagner classification system with the diagnosis of a specialist doctor
Intervention groups
The members of the intervention group will be trained in 5 sessions based on the self-care training package based on the Bezenf model for diabetic wound care. The time of each session will be between 1 and 2 hours depending on the content of each session. The educational package is based on the Bezenf model and the latest diabetic wound care guidelines. The members of the intervention group will be monitored by the researcher on a weekly basis after the end of the intervention until the next three months, and the correct implementation of the trainings will be emphasized. If needed, face-to-face follow-up sessions will be considered.
The members of the control group will be given only the wound care training that is routinely provided in the clinic.
Main outcome variables
wound healing rate; wound healing time; number of wound infections; amputation rate; Knowledge and awareness of patients about diabetic foot ulcer care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240526061901N1
Registration date:2024-08-10, 1403/05/20
Registration timing:prospective
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Zahra Bakhshayesh Ardestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3500 2000
Email address
zahrabakhshayesh82@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Self-Care Educational Program Based on the BASNEF Model on Diabetic Foot Ulcer Care in Patients Referring to Shahid Shabani Nejad Diabetes Clinic in 2024
Public title
Investigating the effect of self-care on diabetic foot ulcers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research
Diagnosis of type 2 diabetes by an endocrinologist
Having grade 1 to 3 diabetic foot ulcer by Wagner classification system with the diagnosis of a specialist doctor
Exclusion criteria:
Being under 18 years of age
Diagnosis of type 1 diabetes
Having grade 4 and 5 diabetic foot ulcers that require amputation as diagnosed by a specialist doctor
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research is available sampling based on the entry criteria and then they were randomly divided into two intervention and control groups. The samples will be divided into two groups of 60 and the block method will be used. They will be CTTC, CTCT, CCTT, TCCT, TCTC, TTCC. where T is for the intervention group and C is for the control group. The numbers will be randomly generated with the RANDBETWEEN command in Excel and in the range of 0 to 6. According to the production values, one of the blocks (for a production number between 0 and 1 CTTC block, for a production number between 1 and 2 CTCT blocks and so on) will be selected and the samples will be allocated accordingly. The study is conducted with a one-way blinding method. In this way, the participants are not aware of the allocation of study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each of the participants will be assigned a unique identification number, and then using the randomization sequence, they will be randomly assigned to two intervention or control groups. Participants will be unaware of study group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2024-04-21, 1403/02/02
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.018
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer
Primary outcomes
1
Description
Wound healing rate
Timepoint
The effectiveness of the self-care training program based on the BASNEF model for the care of diabetic foot ulcers will be investigated in terms of wound healing rate, immediately, one month and three months after the completion of the training sessions, in two intervention and control groups.
Method of measurement
Wagner's diabetic wound classification system
2
Description
Wound healing time
Timepoint
The effectiveness of self-care training program based on the BASNEF model for the care of diabetic foot ulcers will be investigated in terms of wound healing time, immediately, one month and three months after the completion of the training sessions, in two intervention and control groups.
Method of measurement
Wagner diabetic ulcer classification system and demographic information form
3
Description
Number of wound infections
Timepoint
The effectiveness of self-care training program based on the BASNEF model for the care of diabetic foot ulcers will be investigated in terms of the number of wound infections, immediately, one month and three months after the completion of the training sessions, in two intervention and control groups.
Method of measurement
Demographic information form
4
Description
Amputation rate
Timepoint
The effectiveness of the self-care training program based on the BASNEF model for the care of diabetic foot ulcers in terms of the rate of progression of the patient's wound towards amputation, immediately, one month and three months after the completion of the training sessions, will be investigated in two intervention and control groups.
Method of measurement
Demographic information form
5
Description
Knowledge and awareness of patients about diabetic foot ulcer care
Timepoint
The effectiveness of a self-care educational program based on BASNEF model for diabetic foot ulcer care in the field of patients' knowledge and awareness about diabetic foot ulcer care will be investigated immediately, one month and three months after the end of the training sessions, in two intervention and control groups.
Method of measurement
Diabetes self-care questionnaire
6
Description
Self-care score above 68
Timepoint
The effectiveness of a self-care training program based on the BASNEF model for diabetic foot ulcer care will be evaluated immediately after one month and three months after the end of the training sessions in two intervention and control groups.
Method of measurement
Diabetes self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The members of the intervention group will be trained in 5 sessions based on the self-care training package based on the BASNEF model for diabetic wound care. The time of each session will be between 1 and 2 hours, depending on the content of each session. The educational package is based on the Bezenf model and the latest diabetic wound care guidelines.
Category
Behavior
2
Description
Control group: The members of the control group will be given only the wound care training that is routinely provided in the clinic.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Shabani Clinic (diabetes center), Isfahan city
Full name of responsible person
Dr. Hamidreza Afshar
Street address
Shahid Shabani Specialized Clinic, Zarshak Bagh Alley, Chaharbagh Bala, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173686381
Phone
+98 31 3625 8232
Email
isfahan@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Payam Najafi
Street address
Room 323, 3rd floor, Andisheh building, Islamic Azad University (Khorasgan), University Blvd, Arghwanieh, East J St., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2551
Email
Research@khuisf.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
Islamic Azad University
Full name of responsible person
Zahra Bakhshayesh Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
zahrabakhshayesh82@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Minoo Mottaghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
M.motaghi912@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Bakhshayesh Ardestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Islamic Azad University, Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2000
Email
zahrabakhshayesh82@gmail.com
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
The data set used in this study can be accessed after de-identifying the individuals upon reasonable request from the author, Dr. Minoo Motaghi.
Email: M.motaghi912@khuisf.ac.ir
Phone: 00983135002000
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
The data set used in this study can be accessed after de-identifying the individuals upon reasonable request from the author, Dr. Minoo Motaghi.
Email: M.motaghi912@khuisf.ac.ir
Phone: 00983135002000
When the data will become available and for how long
The access period starts 6 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
Use in other similar studies
From where data/document is obtainable
The data set used in this study can be accessed after de-identifying the individuals upon reasonable request from the author, Dr. Minoo Motaghi.
Email: M.motaghi912@khuisf.ac.ir
Phone: 00983135002000
What processes are involved for a request to access data/document
To access the data of this study, send your request to Dr. Minoo Motaghi and if approved, it will be sent within 10 working days.