Online Diabetic Foot Support Program- Care Kit

NCT06760416 | Active Not Recruiting

• 1 other identifier: DokuzEU-IHS-MG-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.).

Conditions

Diabetes Mellitus; Diabetic Foot Ulcer; Diabetic Foot

Keywords

Diabetic Foot; Type 2 Diabetes; Nursing Education; Foot

Outcome Measures

Primary Outcomes (3)

• The 5-item Diabetes Foot Care Knowledge Scale

  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.

  two week

• Foot Self Care Observation Guide

  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.

  two week

• Diabetic Foot Care Self Efficacy Scale

  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.

  two week

Study Arms (2)

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

Other: Nursing Education

CONTROL GROUP

NO INTERVENTION

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

Interventions

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

Experimental Groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merve GÃnbaAY: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylül University

Izmir, Buca, 35380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Diabetes Mellitus, Type 2

Interventions

Nursing Education Research

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nursing Research; Nursing Process; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Merve M GÜNBAŞ, Msc. Phd.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is conducted by dividing patients into experimental and control groups using simple randomization.

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: November 1, 2024
• Primary Completion: December 27, 2024
• Study Completion: March 31, 2025
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)