Diabetic Foot, Mobile Application, Patient EducationNCT04265469
Mobile Application For Educating Diabetics About Foot Care
A study testing Diabetic foot education in people with Diabetic Foot, Mobile Application, Patient Education, run by Istanbul Medeniyet University.
Trial summary
Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Foot, Mobile Application, Patient Education
- What is being tested?
- Diabetic foot education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2016to 7 Nov 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as a Type 2 diabetic according to ADA criteria at least six months prior to the study,
- being 18 years of age and over,
- being literate and fluent in Turkish,
- not having an active foot ulcer,
- owning and being able to operate a smart phone,
- not having any communication or mental problems,
- consenting to participating in the research.
Who cannot join
- Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.
About this study
Official title: The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study
Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.
Read the detailed description
The universe of this randomized controlled study consisted of 130 patients who had presented to a training and research hospital in Istanbul. The data were collected during the period March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the Mobile Application Training.
- Being tested
- Diabetic foot education
- Keywords
- Diabetic foot, mobile application, patient education
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic foot educationOther
Give Diabetic foot education via mobile phone
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetics get mobile education | Experimental | Patients with diabetics get mobile education Receives: Other: Diabetic foot education |
| Patients with diabetics | No intervention | Patients with diabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
their self-efficacy
Diabetic Foot Care Self-efficacy Scale is a scale that determines a diabetic individual's perception of self-efficacy with respect to executing diabetic foot care activities. Responses to this nine-item 10-point Likert-type of questionnaire are assessed on a visual scale that ranges from "I'm absolutely unsure=0" to "I'm very sure=10". The lowest possible score on the scale is 0; the highest is 100.
Measured: change from baseline self efficiancy at week 4.
Diabetes Foot Knowledge
Diabetes Foot Knowledge Questionnaire (DFKQ) were developed by Garcia et al. as a 5-item instrument that assesses the level of knowledge patients have about foot care. The questionnaire is evaluated on the basis of the total score. An increase in the score indicates that the diabetic individual has an increased level of knowledge about foot care
Measured: change from baseline Diabetes Foot Knowledge at week 4.
Foot Self-care Behavior
Foot Self-care Behavior Scale assesses self-efficacy behavior in the context of foot care. It is a 16-item 5-point Likert-type of scale in which responses are assessed as "I do this: 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always." The lowest possible score on the scale is 16; the highest is 80
Measured: change from baseline Foot Self-care Behavior at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start10 Feb 2016
- Primary completion7 Feb 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot, Mobile Application, Patient EducationStudies 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
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dincer, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265469
- Sponsor's protocol ID
- 42432568
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04265469
- Acronym / sponsor ID
- 42432568
- Keywords
- Diabetic foot, mobile application, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 11 Feb 2020 (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.
Purpose: Our aim was to develop a training program on the mobile application and to assess the effect of this training on the participants' knowledge about foot care, their self-efficacy and their behavior levels.
Detailed description
The universe of this randomized controlled study consisted of 130 patients who had presented to a training and research hospital in Istanbul. The data were collected during the period March-September 2017 with an Information Form, the Diabetic Foot Knowledge Scale, Diabetic Foot Care Self-efficacy Scale, Foot Self-care Behavior Scale and a Feedback Form on the Mobile Application Training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetics get mobile education | Experimental | Other: Diabetic foot educationPatients with diabetics get mobile education |
| Patients with diabetics | No intervention | –Patients with diabetics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed as a Type 2 diabetic according to ADA criteria at least six months prior to the study,
- being 18 years of age and over,
- being literate and fluent in Turkish,
- not having an active foot ulcer,
- owning and being able to operate a smart phone,
Key exclusion criteria (1 listed)
- Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.
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 |
|---|---|---|
| Diabetic foot educationGive Diabetic foot education via mobile phone | Other | Patients with diabetics get mobile education |
Primary outcome
their self-efficacy
Time frame: change from baseline self efficiancy at week 4.
Diabetic Foot Care Self-efficacy Scale is a scale that determines a diabetic individual's perception of self-efficacy with respect to executing diabetic foot care activities. Responses to this nine-item 10-point Likert-type of questionnaire are assessed on a visual scale that ranges from "I'm absolutely unsure=0" to "I'm very sure=10". The lowest possible score on the scale is 0; the highest is 100.
Diabetes Foot Knowledge
Time frame: change from baseline Diabetes Foot Knowledge at week 4.
Diabetes Foot Knowledge Questionnaire (DFKQ) were developed by Garcia et al. as a 5-item instrument that assesses the level of knowledge patients have about foot care. The questionnaire is evaluated on the basis of the total score. An increase in the score indicates that the diabetic individual has an increased level of knowledge about foot care
Foot Self-care Behavior
Time frame: change from baseline Foot Self-care Behavior at week 4.
Foot Self-care Behavior Scale assesses self-efficacy behavior in the context of foot care. It is a 16-item 5-point Likert-type of scale in which responses are assessed as "I do this: 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always." The lowest possible score on the scale is 16; the highest is 80
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic foot education in people with Diabetic Foot, Mobile Application, Patient Education, run by Istanbul Medeniyet University.
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 7 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: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
their self-efficacy (time frame: change from baseline self efficiancy at week 4.). The study lists 3 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 11 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.