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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07813676
Enrollment
90
Registered
2026-09-10
Start date
2026-09-20
Completion date
2027-07-31
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes, Diabetic Foot, Digital Education, Foot Care Education, Self-Care Behavior, Self-Efficacy

Brief 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.

Interventions

BEHAVIORALDigital-Supported Foot Care Education

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.

Sponsors

Siirt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Diabetic Foot Care KnowledgeBaseline and at the end of Week 4Diabetic 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 BehaviorBaseline and at the end of Week 4Diabetic 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-EfficacyBaseline and at the end of Week 4Diabetic 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTZeliha Büyükbayram Genç, PhD
zeliha_bbayram@hotmail.com+905533931157
PRINCIPAL_INVESTIGATORZeliha Büyükbayram Genç, PhD

Siirt University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026