DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman (DiaFootCare)
This study aims to evaluate DiaFootCare, a mobile health application designed to support self-care and monitoring among adults with diabetic foot ulcers. The application provides educational and self-care support, medication and care reminders, wound monitoring using standardized foot photographs, and communication of relevant information to support pharmacist-led monitoring.
The study will evaluate the usability and effectiveness of DiaFootCare among patients with diabetic foot ulcers receiving care at the National Diabetes and Endocrine Centre in Oman. Participants using DiaFootCare will be compared with participants receiving usual care. The study will assess outcomes related to diabetic foot self-care, medication adherence, glycemic control, wound healing, and participants' use of and engagement with the application.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Raqiya AL Mamari
- Telefoonnummer: 0096896794009
- E-mail: raqiyaalmamari@gmail.com
Studie Locaties
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Muscat, Oman, 119
- Werving
- National Diabetes and Endocrine Centre
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Contact:
- Issa Al Salmi
- Telefoonnummer: 0096822357280
- E-mail: nhrc-dgp@moh.gov.om
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- - Adults aged 30 to 80 years.
- Diagnosed with type 1 or type 2 diabetes mellitus.
- Have an active diabetic foot ulcer.
- Have access to a compatible smartphone and internet connection.
- Able to understand Arabic and use the DiaFootCare application after receiving instructions.
- Willing and able to provide written informed consent and complete the three-month follow-up.
Exclusion Criteria:
- Severe cognitive, visual, physical, or communication impairment that prevents use of the application or completion of study assessments.
- A diabetic foot condition requiring immediate hospitalization or urgent major surgical intervention.
- Unable or unwilling to complete the three-month follow-up.
- Concurrent participation in another intervention study that could affect the study outcomes.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: DiaFootCare Intervention
Participants assigned to this arm will receive usual diabetic foot care plus access to the DiaFootCare mobile application for three months. The application provides diabetic foot self-care education, medication and self-care reminders, guided wound-image capture, wound monitoring and progress visualization, and pharmacist-led monitoring and support. |
Participants will use the DiaFootCare mobile application for three months in addition to usual diabetic foot care. The application provides diabetic foot self-care education, medication and self-care reminders, guided wound-image capture, wound monitoring and progress visualization, and pharmacist-led monitoring and support. Participants will receive routine diabetic foot ulcer care according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period. |
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Actieve vergelijker: Usual Care Control
Participants assigned to this arm will receive the usual diabetic foot care provided without access to the DiaFootCare mobile application during the three-month study period. |
Participants will receive routine diabetic foot ulcer care according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Complete Wound Closure (100% Epithelialization):
Tijdsspanne: Baseline and 3 months
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The primary effectiveness outcome is complete wound closure-defined as 100% epithelialization of the wound surface with no measurable length, width, or depth-assessed by a podiatrist masked to group allocation at Week 12 (12 weeks from baseline). |
Baseline and 3 months
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Wound dimensions (length, width, area)
Tijdsspanne: Baseline, Week 4, Week 8, Week 12
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Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT |
Baseline, Week 4, Week 8, Week 12
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Glycemic Control Measures
Tijdsspanne: 3 MONTHS
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HbA1c levels, extracted from existing medical records, where routinely available to avoid an additional dedicated blood draw. The laboratory method and/or assay used for measuring HbA1c will be recorded to assure consistency. Where possible, measurements taken by the same lab are used |
3 MONTHS
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Change in Foot Care Confidence (Foot Care Confidence Scale)
Tijdsspanne: 3 months
|
Foot care self-efficacy was assessed using the Foot Care Confidence Scale (FCCS), a 12-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 5-point Likert-type scale. Total scores range from a minimum of 12 to a maximum of 60, with higher scores indicating greater confidence in performing foot self-care. |
3 months
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Change in Diabetes Management Self-Efficacy (Diabetes Management Self-Efficacy Scale)
Tijdsspanne: 3 months
|
Self-efficacy in diabetes management was assessed using the Diabetes Management Self-Efficacy Scale (DMSES), a 20-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 1-5 numerical scale reflecting the respondent's level of efficacy expectation. Total scores range from a minimum of 20 to a maximum of 100, with higher scores indicating greater self-efficacy in diabetes management. |
3 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Vaatziekten
- Hart-en vaatziekten
- Metabole ziekten
- Glucosemetabolismestoornissen
- Diabetische angiopathieën
- Diabetes complicaties
- Huidziektes
- Huidzweer
- Beenzweer
- Diabetische neuropathieën
- Voetzweer
- Gedrag
- Voedings- en stofwisselingsziekten
- Huid- en bindweefselaandoeningen
- Therapietrouw en therapietrouw
- Gezondheidsgedrag
- Naleving van de patiënt
- Patiëntacceptatie van gezondheidszorg
- Suikerziekte
- Diabetische voet
- Medicatie therapietrouw
Andere studie-ID-nummers
- MoH/CSR/24/29355
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Individual participant data will not be shared because the study includes sensitive clinical information and wound images, and external data sharing is not included in the current ethics approval and participant consent.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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