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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Raqiya AL Mamari
- Número de teléfono: 0096896794009
- Correo electrónico: raqiyaalmamari@gmail.com
Ubicaciones de estudio
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Muscat, Omán, 119
- Reclutamiento
- National Diabetes and Endocrine Centre
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Contacto:
- Issa Al Salmi
- Número de teléfono: 0096822357280
- Correo electrónico: nhrc-dgp@moh.gov.om
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Complete Wound Closure (100% Epithelialization):
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Glycemic Control Measures
Periodo de tiempo: 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)
Periodo de tiempo: 3 months
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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)
Periodo de tiempo: 3 months
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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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Enfermedades de la piel
- Úlcera de la piel
- Úlcera en la pierna
- Neuropatías diabéticas
- Úlcera del pie
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Diabetes mellitus
- Pie diabético
- Adherencia a la medicación
Otros números de identificación del estudio
- MoH/CSR/24/29355
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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