Online Diabetic Foot Support Program- Care Kit

NCT ID: NCT06760416

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Diabetic Foot Ulcer Diabetic Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is conducted by dividing patients into experimental and control groups using simple randomization.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental Groups

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

Group Type EXPERIMENTAL

Nursing Education

Intervention Type OTHER

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

CONTROL GROUP

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nursing Education

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Merve GÃnbaAY

OTHER

Sponsor Role lead

Responsible Party

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Merve GÃnbaAY

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Merve M GÜNBAŞ, Msc. Phd.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Dokuz Eylül University

Izmir, Buca, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DokuzEU-IHS-MG-01

Identifier Type: -

Identifier Source: org_study_id

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