Effect of Digital-Supported Foot Care Education in Individuals With Type 2 Diabetes

NCT07813676 — Not applicable, Not yet recruiting, 90 participants, Siirt University

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The Effect of Digital-Supported Foot Care Education on Knowledge, Self-Care Behavior, and Self-Efficacy in Individuals With Type 2 Diabetes: A Randomized Controlled Trial

Registry	NCT07813676
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	90 (Estimated)
Sponsor	Siirt University (Other)
Conditions	Type 2 Diabetes Mellitus (T2DM)
Interventions	Digital-Supported Foot Care Education (Behavioral)
Dates	start 2026-09-20 (estimated), primary completion 2027-07-15 (estimated), completion 2027-07-31 (estimated), first posted 2026-09-10, last updated 2026-09-10
Locations	1 site in Turkey (Türkiye)

-Summary

This randomized controlled trial will evaluate the effect of digital-supported foot care education on foot care knowledge, self-care behaviors, and self-efficacy in individuals with type 2 diabetes. A total of 90 participants will be randomly assigned to an intervention group (n=45) or a control group (n=45). Participants in the intervention group will receive structured foot care education supported by videos and visual materials accessible through QR codes, together with hands-on training using a diabetic foot model. Participants in the control group will receive standard care. Foot care knowledge, self-care behaviors, and foot care self-efficacy will be assessed before and after the intervention. The study aims to determine whether digital-supported foot care education is effective in improving these outcomes among individuals with type 2 diabetes.

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+Arms and interventions

Arm	Type	Interventions	Description
Digital-Supported Foot Care Education Group	Experimental	Behavioral: Digital-Supported Foot Care Education	Participants assigned to the intervention group will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will be supported by QR code-accessible video and visual materials and hands-on demonstrations using a diabetic foot model. Participants will be encouraged to access the digital materials at least twice a week for four weeks and will receive regular reminders via text messages and/or telephone calls.
Control Group	No intervention		Participants assigned to the control group will continue to receive routine care and will not receive the digital-supported foot care education during the study period. After completion of the study, the educational materials will be offered to control group participants who wish to receive them.

Digital-Supported Foot Care Education (Behavioral): Participants will receive two individual face-to-face foot care education sessions, each lasting 20-25 minutes. The education will include practical demonstrations using a diabetic foot model and will be supported by video and visual materials accessible via QR codes. Participants will be encouraged to access the digital materials at least twice a week for four weeks. During this period, regular reminders will be provided via text messages and/or telephone calls to support continued engagement with the educational materials.

+Outcome measures

Primary outcomes

Change in Diabetic Foot Care Knowledge [Baseline and at the end of Week 4]: Diabetic foot care knowledge will be assessed using the Diabetic Foot Knowledge Scale. The scale consists of 5 items, with total scores ranging from 0 to 5. Higher scores indicate a higher level of diabetic foot care knowledge. Change in scores from baseline to the end of the 4-week intervention period will be evaluated.
Change in Diabetic Foot Self-Care Behavior [Baseline and at the end of Week 4]: Diabetic foot self-care behavior will be assessed using the Diabetic Foot Self-Care Behavior Scale. The scale consists of 7 items, with total scores ranging from 7 to 35. Higher scores indicate better diabetic foot self-care behavior. Change in scores from baseline to the end of Week 4 will be evaluated.
Change in Diabetic Foot Care Self-Efficacy [Baseline and at the end of Week 4]: Diabetic foot care self-efficacy will be assessed using the Diabetic Foot Care Self-Efficacy Scale. The scale consists of 9 items rated from 0 (not at all confident) to 10 (very confident). Higher scores indicate greater diabetic foot care self-efficacy. Change in scores from baseline to the end of Week 4 will be evaluated.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus according to ICD-10 criteria for at least 6 months.
* Age 18 years or older.
* Stable general health condition.
* No condition that would prevent communication or understanding of the education, including severe cognitive, hearing, or speech impairment.
* Ability to communicate in Turkish and sufficient cognitive ability to understand the education.
* Voluntary participation and provision of written informed consent.
* Ability to access video and visual educational materials via QR codes either independently or with the assistance of a relative/caregiver.

Exclusion Criteria:

* Previous participation in a structured diabetic foot care education program.
* Presence of an active diabetic foot ulcer or a history of amputation.
* Presence of a serious neurological or orthopedic condition, other than diabetes-related conditions, that may directly affect foot care.
* Anticipated inability to regularly participate in the planned education and follow-up procedures.
* Presence of an acute complication of diabetes requiring emergency clinical intervention.

+Locations (1)

Facility	City	Country	Status
Siirt Training and Research Hospital	Siirt, Siirt	Turkey (Türkiye)

+Investigators

Zeliha Büyükbayram Genç, PhD, Principal investigator, Siirt University