Clinical trial NCT06760416: Online Diabetic Foot Support Program- Care Kit
Official title: Effect of Online Diabetic Foot Support Program (DiaFootSuP) and Care Kit on Diabetic Foot Care Outcomes: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Foot Ulcer
Diabetic Foot
Keywords: Diabetic Foot
Type 2 Diabetes
Nursing Education
Foot
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-01-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is conducted by dividing patients into experimental and control groups using simple randomization.
Primary purpose: PREVENTION

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.).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The 5-item Diabetes Foot Care Knowledge Scale
timeFrame: two week
measure: Foot Self Care Observation Guide
timeFrame: two week
measure: Diabetic Foot Care Self Efficacy Scale
timeFrame: two week
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
state: Buca
Study officials:
affiliation: Dokuz Eylul University
name: Merve M GÜNBAŞ, Msc. Phd.
role: PRINCIPAL_INVESTIGATOR
References: