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

4. september 2026 oppdatert av: Zeliha Buyukbayram Genç, Siirt University

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

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Digital-Supported Foot Care Education Group
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.
Atferdsmessig: Digital-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.
Ingen inngripen: Control Group
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Diabetic Foot Care Knowledge
Tidsramme: 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.
Baseline and at the end of Week 4
Change in Diabetic Foot Self-Care Behavior
Tidsramme: 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.
Baseline and at the end of Week 4
Change in Diabetic Foot Care Self-Efficacy
Tidsramme: 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.
Baseline and at the end of Week 4

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Siirt University

Etterforskere

  • Hovedetterforsker: Zeliha Büyükbayram Genç, PhD, Siirt University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. september 2026

Primær fullføring (Antatt)

15. juli 2027

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

4. september 2026

Først innsendt som oppfylte QC-kriteriene

4. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-SİÜSBF-016 (Annet stipend/finansieringsnummer: Siirt University Scientific Research Projects Coordination Unit)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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