Type2diabetesNCT05473494
THE EFFECT OF ONLINE TRAINING ON FOOT CARE
A study testing training group in people with Type2diabetes and Diabetic Foot, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2diabetes, Diabetic Foot
- What is being tested?
- training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Sep 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.
- To be able to read and write.
- Being between the ages of 18-65.
- Being on oral antidiabetic (OAD) and/or insulin therapy.
- No restriction of access to the Internet.
- To be able to use the Zoom program or WhatsApp video conversation with or without support.
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- Having computer and/or telephone skills.
- Volunteering to participate in the study (Informed consent form will be signed by the participants during the application)
- Not having sensory loss such as speech and hearing that prevents communication and no psychiatric problems.
Who cannot join
- outside the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ev
Kocaeli, Izmit, 41500
About this study
Official title: THE EFFECT OF ONLINE TRAININGS ON DIABETIC FOOT CARE ON FOOT CARE BEHAVIOR AND SELF-EFFECTIVENESS ATTITUDES OF INDIVIDUALS WITH TYPE II DIABETES
The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes.
Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment
- Conditions
- Type2diabetes, Diabetic Foot
- Being tested
- training group, control group
- Keywords
- Type2diabetes, DiabeticFootCare, OnlineEducational, DistanceEducation, Self-Effectıveness
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training groupOther
Trainings on diabetic foot care consisting of min 20 max 40 minutes will be given in 5 sessions for nine weeks. Training will be given face to face online.
control groupOther
Group not to be trained.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | Not described Receives: Other: training group |
| control group | Active comparator | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic Foot Care Self-Efficacy Scale
Self-efficacy is measured by scoring between 0 and 10. The 9 expressions that make up the scale are evaluated on the 11-digit visual scale, which is specified as -Not sure=0 and very sure=10. The lowest score of the scale is 0 and the highest score is 100. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases in parallel.
Measured: nine weeks
Secondary outcomes (1)
Foot Care Behavıor Scale
Consisting of 15 items in a 5-point Likert type, the scale is scored according to agree-disagree (1= Never, 2= Occasionally, 3= Sometimes, 4= Often, and 5= Always) and consists of 15 items. The lowest score that can be obtained from the scale, which evaluates foot care behavior as a single dimension, is 15 and the highest score is 75. An increase in the scale score indicates that the individual's foot self-care behaviors become positive.
Measured: nine weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Jan 2022
- Primary completion25 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Kandemir, Maltepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473494
- Sponsor's protocol ID
- 2021/33-03
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF ONLINE TRAININGS ON DIABETIC FOOT CARE ON FOOT CARE BEHAVIOR AND SELF-EFFECTIVENESS ATTITUDES OF INDIVIDUALS WITH TYPE II DIABETES
- ClinicalTrials.gov ID
- NCT05473494
- Acronym / sponsor ID
- 2021/33-03
- Conditions
- Type2diabetes, Diabetic Foot
- Keywords
- Type2diabetes, DiabeticFootCare, OnlineEducational, DistanceEducation, Self-Effectıveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 25 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Jul 2022 (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 aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes.
Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Other: training group |
| control group | Active comparator | Other: control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who were applied the Dietetic Foot Risk Screening form during the physician's examination and who were in the low and medium risk groups after the physician's examination.
- To be able to read and write.
- Being between the ages of 18-65.
- Being on oral antidiabetic (OAD) and/or insulin therapy.
- No restriction of access to the Internet.
Key exclusion criteria (1 listed)
- outside the inclusion criteria.
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 |
|---|---|---|
| training groupTrainings on diabetic foot care consisting of min 20 max 40 minutes will be given in 5 sessions for nine weeks. Training will be given face to face online. | Other | training group |
| control groupGroup not to be trained. | Other | control group |
Primary outcome
Diabetic Foot Care Self-Efficacy Scale
Time frame: nine weeks
Self-efficacy is measured by scoring between 0 and 10. The 9 expressions that make up the scale are evaluated on the 11-digit visual scale, which is specified as -Not sure=0 and very sure=10. The lowest score of the scale is 0 and the highest score is 100. As the score obtained from the scale increases, the diabetic foot self-efficacy level increases in parallel.
1 secondary outcome
Foot Care Behavıor Scale
Time frame: nine weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training group in people with Type2diabetes and Diabetic Foot, run by Maltepe 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 9 inclusion and 1 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 26 Jul 2022. 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?
Contact Ayşegül Kandemir (5433837160 ext. +90, aysegul.kanfe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic Foot Care Self-Efficacy Scale (time frame: nine weeks). 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 26 Jul 2022.