NCT04265469

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

February 7, 2020

Last Update Submit

February 10, 2020

Conditions

Keywords

Diabetic foot, mobile application, patient education

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Patients with diabetics get mobile education

EXPERIMENTAL

Patients with diabetics get mobile education

Other: Diabetic foot education

Patients with diabetics

NO INTERVENTION

Patients with diabetics

Interventions

Give Diabetic foot education via mobile phone

Patients with diabetics get mobile education

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

February 10, 2016

Primary Completion

February 7, 2017

Study Completion

November 7, 2017

Last Updated

February 11, 2020

Record last verified: 2020-02