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Mobile Application For Educating Diabetics About Foot Care

Primary Purpose

Diabetic Foot, Mobile Application, Patient Education

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diabetic foot education
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot, Mobile Application, Patient Education focused on measuring Diabetic foot, mobile application, patient education

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Patients with diabetics get mobile education

    Patients with diabetics

    Arm Description

    Patients with diabetics get mobile education

    Patients with diabetics

    Outcomes

    Primary Outcome Measures

    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.
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 7, 2020
    Last Updated
    February 10, 2020
    Sponsor
    Istanbul Medeniyet University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04265469
    Brief Title
    Mobile Application For Educating Diabetics About Foot Care
    Official Title
    The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 10, 2016 (Actual)
    Primary Completion Date
    February 7, 2017 (Actual)
    Study Completion Date
    November 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul Medeniyet University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot, Mobile Application, Patient Education
    Keywords
    Diabetic foot, mobile application, patient education

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with diabetics get mobile education
    Arm Type
    Experimental
    Arm Description
    Patients with diabetics get mobile education
    Arm Title
    Patients with diabetics
    Arm Type
    No Intervention
    Arm Description
    Patients with diabetics
    Intervention Type
    Other
    Intervention Name(s)
    Diabetic foot education
    Intervention Description
    Give Diabetic foot education via mobile phone
    Primary Outcome Measure Information:
    Title
    their self-efficacy
    Description
    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.
    Time Frame
    change from baseline self efficiancy at week 4.
    Title
    Diabetes Foot Knowledge
    Description
    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
    Time Frame
    change from baseline Diabetes Foot Knowledge at week 4.
    Title
    Foot Self-care Behavior
    Description
    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
    Time Frame
    change from baseline Foot Self-care Behavior at week 4.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Mobile Application For Educating Diabetics About Foot Care

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