Mobile Application For Educating Diabetics About Foot Care

February 10, 2020 updated by: Berna Dincer, Istanbul Medeniyet University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with diabetics get mobile education
Other: Diabetic foot education
Give Diabetic foot education via mobile phone
NO_INTERVENTION: Patients with diabetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline self efficiancy at week 4.
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
change from baseline Diabetes Foot Knowledge at week 4.
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
change from baseline Foot Self-care Behavior at week 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2016

Primary Completion (ACTUAL)

February 7, 2017

Study Completion (ACTUAL)

November 7, 2017

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (ACTUAL)

February 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42432568

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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