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临床试验/NCT06760416
NCT06760416进行中(未招募)不适用

Effect of Online Diabetic Foot Support Program (DiaFootSuP) and Care Kit on Diabetic Foot Care Outcomes: Randomized Controlled Trial

Merve GÃnbaAY1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
62
试验地点
1
主要终点
The 5-item Diabetes Foot Care Knowledge Scale

研究概览

简要总结

The aim of this project is to examine the effects of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who have previously had a diabetic foot ulcer on diabetic foot outcomes (diabetic foot knowledge level, foot care behavior level, foot care self-efficacy level, HbA1c, etc.).

详细描述

It was planned as a randomized controlled study to determine the effect of the online diabetic foot support program (DiaFootSuP) and care kit applied to type 2 diabetic individuals who had previously had diabetic foot ulcers on diabetic foot outcomes. The sample calculation of the study was based on determining the difference between two independent groups and the sample size for the experimental and control groups was taken as experimental: 31-control: 31 people using the G*Power 3.1.9.6 program. The experimental group was given a foot care kit developed by the researcher, which included special foot care products. Pre-test data for the experimental and control groups are collected from the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Online diabetic foot care training consisting of 5 modules is given individually to the patients in the experimental group. After the training, motivational messages and informative videos are sent once a week for 3 months. Patients are also asked to send photos while doing foot care. The post-test data of the experimental and control groups will be collected at the end of 3 months with the diabetic foot knowledge scale, foot care behavior scale, and diabetic foot care self-efficacy scale. Training videos will be delivered to the control group at the end of the study.

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 (Participant)

入排标准

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

入选标准

  • •18 years of age or older, Individuals diagnosed with type 2 diabetes, Patients who have had diabetic foot ulcers and have healed, Can read and write Turkish, No visual, hearing, perception and any physical disability, Physical, mental and cognitive competence to participate in self-care activities, Able to use technological products (able to use computers, tablets and smartphones), Individuals who voluntarily agree to participate in the study will constitute the sample

排除标准

  • •Patients with active diabetic foot ulcers, Individuals who cannot read or write, Individuals who cannot use technological devices, Individuals who do not want to participate in the study

研究组 & 干预措施

Experimental Groups

Experimental

5 modules of online foot care training, motivational messages and informative videos for the patient who was given a foot care kit

干预措施: Nursing Education (Other)

CONTROL GROUP

No Intervention

Delivery of training videos after pre-test and post-test application

结局指标

主要结局

The 5-item Diabetes Foot Care Knowledge Scale

时间窗: two week

The 5-item Diabetes Foot Care Knowledge Scale, a subscale of the Diabetes Knowledge Questionnaire-24, was used. Cronbach's α value was found to be 0.63. Scores range from 0 to 5, with higher scores indicating higher knowledge levels.

Foot Self Care Observation Guide

时间窗: two week

The Cronbach α value of the Foot Self Care Observation Guide was determined as 0.83. The scale consists of 15 items. These items are evaluated as 1=Never, 2=Occasionally, 3=Sometimes, 4=Frequently, 5=Always. The lowest score on the scale is 15, the highest is 75. An increase in the scale score indicates that the individual's self-care behaviors are better.

Diabetic Foot Care Self Efficacy Scale

时间窗: two week

Diabetic Foot Care Self Efficacy Scale Cronbach α value was determined as 0.86. The scale consists of nine items. These nine statements are evaluated on an 11-number visual scale, which is stated as "I do not see it as sufficient at all = 0" and "I see it as very sufficient = 10". The lowest score obtained from the scale is 0, the highest score is 90. An increase in the scale score indicates that the individual has high self-efficacy.

次要结局

未报告次要终点

研究者

发起方
Merve GÃnbaAY
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merve GÃnbaAY

Principal Investigator

Dokuz Eylul University

研究点 (1)

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