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Active, Not Recruiting

NCT Number: NCT06760416

Online Diabetic Foot Support Program- Care Kit

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.).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Diabetes Complications Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylül University

Izmir, Buca, 35380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Nursing education

Other

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

Primary outcomes

  1. The 5-item Diabetes Foot Care Knowledge Scale

    Time frame: 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.

  2. Foot Self Care Observation Guide

    Time frame: 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.

  3. Diabetic Foot Care Self Efficacy Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merve GÃnbaAY

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Acronym: DiaFootSuP

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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