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临床试验/NCT04265469
NCT04265469已完成不适用

The Effect of Mobile Application in Foot Care of Type 2 Diabetes Patients: A Randomized Controlled Study

Istanbul Medeniyet University0 个研究点目标入组 130 人开始时间: 2016年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
主要终点
Diabetes Foot Knowledge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Diabetes Foot Knowledge

时间窗: 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

时间窗: 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

their self-efficacy

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Berna Dincer

Assistant Professor

Istanbul Medeniyet University

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