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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiirt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Digital-Supported Foot Care Education GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Diabetic Foot Care Knowledge

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.

Time frame
Baseline and at the end of Week 4
2

Change in Diabetic Foot Self-Care Behavior

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.

Time frame
Baseline and at the end of Week 4
3

Change in Diabetic Foot Care Self-Efficacy

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.

Time frame
Baseline and at the end of Week 4

Secondary outcomes

Other outcomes

Sponsors and contacts

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