Diabetic Foot UlcerNCT06213337
Virtual Classroom Training and SMS Supported Interventions Improving Foot Care and Self-Efficacy
A study testing Foot care training with virtual classroom, Foot care training with SMS support and Foot care training with virtual classroom and SMS support in people with Diabetic Foot Ulcer, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Foot care training with virtual classroom, Foot care training with SMS support and Foot care training with virtual classroom and SMS support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Reporting that you have internet, computer/smartphone access
- Becoming literate
- Ability to use the internet and mobile devices effectively
- Declaring that you are competent to use technology-based training
- Being between the ages of 18-55
- Diagnosis period of 1 year or more
Who cannot join
- Having a psychiatric/neurological disability that may prevent participation in the research
- Having any diagnosis of learning disability
- Having an existing foot ulcer
- Having a history of foot ulcers and amputation in the past
- Having severe vision problems/retinopathy
- Having severe hearing impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55270
About this study
Official title: Evaluation of the Effectiveness of Virtual Classroom Training and SMS Supported Interventions in Improving Foot Care Behaviors and Foot Care Self-Efficacy of Diabetic Patients
The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients.
The basic questions the research aims to answer are:
Read more
- Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients?
- Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent.
In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Foot care training with virtual classroom, Foot care training with SMS support, Foot care training with virtual classroom and SMS support
- Keywords
- diabetic foot, virtual systems, Short Message Service
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot care training with virtual classroomOther
Providing foot care training once every two weeks in virtual classes created via the Google meet application.
Foot care training with SMS supportOther
Total of 60 SMS messages containing foot care information will be sent, one every day.
Foot care training with virtual classroom and SMS supportOther
Providing foot care training once every two weeks in virtual classes created via the Google meet application. Furthermore, total of 60 SMS messages containing foot care information will be sent, one every day.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No intervention will be applied to this group. |
| virtual classroom group | Experimental | Participants in this group will be given virtual classroom training on foot care. Receives: Other: Foot care training with virtual classroom |
| SMS support group | Experimental | Information regarding foot care will be sent via SMS to the participants in this group. Receives: Other: Foot care training with SMS support |
| SMS supported virtual classroom training group | Experimental | Participants in this group will be given virtual classroom training with SMS support. Receives: Other: Foot care training with virtual classroom and SMS support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of foot care behavior in diabetic patients
Foot Care Behavior Scale Total Score increasing
Measured: within 3 months
Development of foot care self-efficacy in diabetic patients
Foot Care Self-Efficacy Scale Total Score increasing
Measured: within 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Mar 2023
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Arslan, Ondokuz Mayıs University
- Investigators
- Burak Arslan, Lecturer, Principal investigator, Hitit UniversityAfitap Özdelikara, Assoc. Prof., Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213337
- Sponsor's protocol ID
- BArslan
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Virtual Classroom Training and SMS Supported Interventions in Improving Foot Care Behaviors and Foot Care Self-Efficacy of Diabetic Patients
- ClinicalTrials.gov ID
- NCT06213337
- Acronym / sponsor ID
- BArslan
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetic foot, virtual systems, Short Message Service
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The type of this research is a randomized controlled experimental study. The aim of the research is to determine the effectiveness of virtual classroom training and SMS support in improving foot care behaviour and foot care self-efficacy in diabetic patients.
The basic questions the research aims to answer are:
- Is virtual classroom training effective in improving foot care behaviour and foot care self-efficacy in diabetic patients?
- Are SMS-supported interventions effective in improving foot care behaviour and foot care self-efficacy in diabetic patients? Within the scope of the research, participants are expected to attend virtual classroom training and read the SMS sentences sent.
In order to examine the effects of virtual classroom training and SMS-supported interventions, researchers created a control group, a virtual classroom, an SMS support group, and an SMS-supported virtual classroom group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No intervention will be applied to this group. |
| virtual classroom group | Experimental | Other: Foot care training with virtual classroomParticipants in this group will be given virtual classroom training on foot care. |
| SMS support group | Experimental | Other: Foot care training with SMS supportInformation regarding foot care will be sent via SMS to the participants in this group. |
| SMS supported virtual classroom training group | Experimental | Other: Foot care training with virtual classroom and SMS supportParticipants in this group will be given virtual classroom training with SMS support. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Reporting that you have internet, computer/smartphone access
- Becoming literate
- Ability to use the internet and mobile devices effectively
- Declaring that you are competent to use technology-based training
- Being between the ages of 18-55
Key exclusion criteria (6 listed)
- Having a psychiatric/neurological disability that may prevent participation in the research
- Having any diagnosis of learning disability
- Having an existing foot ulcer
- Having a history of foot ulcers and amputation in the past
- Having severe vision problems/retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot care training with virtual classroomProviding foot care training once every two weeks in virtual classes created via the Google meet application. | Other | virtual classroom group |
| Foot care training with SMS supportTotal of 60 SMS messages containing foot care information will be sent, one every day. | Other | SMS support group |
| Foot care training with virtual classroom and SMS supportProviding foot care training once every two weeks in virtual classes created via the Google meet application. Furthermore, total of 60 SMS messages containing foot care information will be sent, one every day. | Other | SMS supported virtual classroom training group |
Primary outcome
Development of foot care behavior in diabetic patients
Time frame: within 3 months
Foot Care Behavior Scale Total Score increasing
Development of foot care self-efficacy in diabetic patients
Time frame: within 1 months
Foot Care Self-Efficacy Scale Total Score increasing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Arslan, Lecturer principal investigator
Hitit University
Afitap Özdelikara, Assoc. Prof. study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot care training with virtual classroom, Foot care training with SMS support and Foot care training with virtual classroom and SMS support in people with Diabetic Foot Ulcer, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of foot care behavior in diabetic patients (time frame: within 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.