Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes

NCT07473050 | Not Yet Recruiting

• 1 other identifier: 26-2.1T/32
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. The study will assess the program's impact on diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health outcomes. The research will be conducted between April and October 2026 at a university hospital diabetes outpatient clinic in İzmir, Türkiye. A total of 70 participants diagnosed with Type II DM will be enrolled and randomly assigned to either the intervention group (n=35) or the control group (n=35) using stratified block randomization. Participants in the intervention group will receive the Virtual Reality-Based "Health to My Foot" program through virtual reality goggles and will have access to a recorded foot care training video for home use. They will also receive weekly motivational reminder messages for three months. The control group will receive standard outpatient care only. Data will be collected at baseline (pre-test), 1 month (post-test), and 3 months (follow-up) using validated scales and a nurse follow-up form to evaluate knowledge, self-efficacy, behaviors, and clinical foot health indicators. The findings are expected to contribute to sustainable patient education strategies and to support the prevention of diabetic foot complications and reduction of healthcare costs.

Conditions

Diabetic Foot - Telemedical Monitoring; Diabetic; Foot Care; Virtual Reality

Keywords

Diabetic foot; Foot care; Virtual Reality; nursing; nursing care

Outcome Measures

Primary Outcomes (1)

• Change in Total Score of the Diabetic Foot Knowledge Scale

  The outcome is the change in the total score of the Diabetic Foot Knowledge Scale (DFKS). The scale assesses participants' knowledge regarding diabetic foot care. Scores are calculated by summing item responses, with higher scores indicating greater knowledge. The change in total score will be calculated by comparing baseline (pre-test), 1-month post-intervention, and 3-month follow-up assessments.

  Baseline, 1 month post-intervention, and 3 months follow-up

Secondary Outcomes (1)

• Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form

  Baseline and 3 months

Study Arms (2)

Control

NO INTERVENTION

This group will not receive any intervention and will receive their routine care and treatment.

Study

EXPERIMENTAL

This group will receive VR-based intervention and will receive their routine care and treatment.

Behavioral: "Health for My Feet" virtual reality program.

Interventions

"Health for My Feet" virtual reality program. BEHAVIORAL

In addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program.

Study

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years of age
• Having been diagnosed with type 2 diabetes for at least one year
• Having a risk level of 0, 1, or 2 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
• Having completed primary education or higher
• Not having hearing, speech, or visual impairments
• Being able to use a smartphone
• Not having received prior training in diabetic foot care
• Being willing to participate in the study

You may not qualify if:

• Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer
• \- Risk level 3 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification
• Having a severe/uncontrolled comorbid disease
• Wishing to withdraw from the study

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Health

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 16, 2026
• Study Start: April 16, 2026
• Primary Completion: May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share