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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04265469
Other study ID # 42432568
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2016
Est. completion date November 7, 2017

Study information

Verified date February 2020
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date November 7, 2017
Est. primary completion date February 7, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Patients with advanced retinopathy and those wishing to withdraw from the research were excluded from the study.

Study Design


Related Conditions & MeSH terms

  • Diabetic Foot
  • Diabetic Foot, Mobile Application, Patient Education

Intervention

Other:
Diabetic foot education
Give Diabetic foot education via mobile phone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. change from baseline self efficiancy at week 4.
Primary 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 change from baseline Diabetes Foot Knowledge at week 4.
Primary 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 change from baseline Foot Self-care Behavior at week 4.