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Implementation of a Preventive Diabetic Foot Care Program for Patients at Risk of Diabetic Foot
Sponsor: Akdeniz University
Summary
This study aims to evaluate the effect of a preventive diabetic foot care program on the knowledge, behavior, self-management, and glycemic control levels of type 2 diabetic patients at risk of diabetic foot. The development of a Preventive Diabetic Foot Care Program (DiaFOOTCare) for patients with type 2 diabetes at risk of diabetic foot is expected to make a significant contribution to preventing diabetic foot formation. The DiaFOOTCare program consists of two stages. In the first phase, a comprehensive, multi-component, and evidence-based preventive diabetic foot care program will be designed specifically for type 2 diabetic patients at risk of diabetic foot. The internal validity of the program will be tested through expert evaluations by specialists in diabetic foot care, assessments using readability formulas, and pre-application testing with patients identified as being at risk of diabetic foot. As part of the final implementation of the first phase, all interventions included in the DiaFOOTCare protocol will be administered to four patients with diabetic foot risk over a three-week period. Following this, the DiaFOOTCare protocol will be evaluated based on the feedback provided by these four pre-application participants. In the second phase, a randomized controlled trial (RCT) with a single-blinded and active control group design will be conducted at the Akdeniz University Hospital Endocrinology and Metabolic Diseases Outpatient Clinic. A group of patients with type 2 diabetes and diabetic foot risk will be identified, and pre-tests will be administered. The patients will then be randomly assigned to the intervention group (n=39) and the control group (n=39). The effectiveness of the DiaFOOTCare program will be assessed through post-tests.
Official title: The Effect of a Preventive Diabetic Foot Care Program on Knowledge, Behavior, Self-Management, and Glycemic Control Levels in Patients at Risk of Diabetic Foot
Key Details
Gender
All
Age Range
30 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2025-02-01
Completion Date
2026-03-01
Last Updated
2025-01-13
Healthy Volunteers
No
Interventions
DiaFOOTCare Program
The DiaFOOTCare Program includes initiatives to support diabetic foot self-management. An e-booklet on type 2 diabetes management and preventive foot care will be shared via WhatsApp or email, along with audio modules for convenient access. An interactive video featuring a simulated patient will visually demonstrate preventive foot care practices and will also be shared digitally. A 25-30-minute face-to-face training session will provide personalized education using a tablet. Goal-tracking cards will be introduced to collaboratively set three-month behavioral goals, with patients documenting their progress during the follow-up. SMS reminders will be sent three times weekly to reinforce adherence. Patients will have digital access to all DiaFOOTCare resources, including the e-booklet, audio modules, and video, for 12 weeks, ensuring accessibility via WhatsApp or email. These measures aim to enhance knowledge, behavior, and self-management practices in preventive diabetic foot care.
Ministry of Health and Education
The active control group will receive routine outpatient follow-ups and a diabetic foot care brochure from the Ministry of Health, explained by the researcher and shared via WhatsApp or email for reference. Goal-tracking cards from the DiaFOOTCare program will be used to set individual diabetic foot self-management behavioral goals collaboratively during the initial interview. Patients will be instructed on how to complete the cards and maintain them over a three-month period. At the end of the follow-up, post-tests will assess outcomes using the Glycemic Control Form, Goal-Tracking Card, Diabetic Foot Knowledge Scale, Foot Care Behavior Scale, Nottingham Functional Foot Care Diagnostic Form, Diabetic Foot Development Follow-up Form, and Diabetic Foot Self-Management Scale. Educational resources, including the e-booklet, audio modules, and video developed in DiaFOOTCare, will also be shared via WhatsApp or email to provide additional support and enhance diabetic foot self-management.