Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot (DF-EDU-RCT)
Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications.
Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility.
The educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period.
The findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Diabetic foot is one of the most serious and common complications of diabetes mellitus, often leading to infection, ulceration, hospitalization, and in severe cases, lower limb amputation. It significantly affects patients' physical, psychological, and social well-being, thereby reducing overall quality of life. Despite the availability of preventive guidelines, many patients continue to demonstrate inadequate foot self-care behaviors, poor adherence to management recommendations, and low self-efficacy in managing their condition.
This study is designed as a randomized controlled trial to assess the effectiveness of a structured educational program on improving clinical and behavioral outcomes among adults with diabetic foot. The study will be conducted at selected healthcare settings, and eligible participants will be randomly allocated into either an intervention group or a control group using a predefined randomization method.
The intervention group will receive a structured educational program delivered through planned teaching sessions. The program is based on evidence-based diabetic foot care guidelines and includes theoretical and practical components. Topics covered include diabetic foot anatomy and risk factors, daily foot inspection techniques, proper hygiene practices, nail and skin care, appropriate footwear selection, wound prevention strategies, glycemic control, and early recognition of complications. Educational materials such as brochures, demonstrations, and interactive discussions will be used to enhance understanding and adherence.
The control group will receive routine care and standard education provided by the healthcare facility without additional structured intervention.
Outcome measures will be assessed at baseline and post-intervention. The primary outcomes include:
Pain intensity measured using a validated pain scale Self-efficacy assessed through a standardized self-efficacy instrument Foot self-care behaviors measured using a diabetic foot care behavior scale Health-related quality of life assessed using a validated quality of life questionnaire
Data will be analyzed to determine the effectiveness of the structured educational program in improving these outcomes compared to routine care.
The study is expected to provide evidence supporting the integration of structured educational programs into nursing practice to improve self-management, reduce complications, and enhance quality of life among patients with diabetic foot.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- Número de teléfono: +962779084560
- Correo electrónico: JAWAD_0799@YAHOO.COM
Ubicaciones de estudio
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Dours
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Jerash, Dours, Jordán, 009627
- Ministry of Health Primary Healthcare Centers
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Contacto:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- Número de teléfono: 0779084560
- Correo electrónico: JAWAD_0799@YAHOO.COM
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Contacto:
- Correo electrónico: JAWAD_0799@YAHOO.COM
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Investigador principal:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged 18 years and older
- Diagnosed with diabetic foot
- Able to communicate effectively
- Willing to participate in the educational program
- Able to provide written informed consent
Exclusion Criteria:
- Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation
- Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments
- Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance
- Pregnant or lactating women
- Patients who refuse to provide informed consent or withdraw at any stage of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Grupo de control
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A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management.
The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications.
Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
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Experimental: Educational Program Group
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A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management.
The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications.
Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity Measured Using the Numeric Rating Scale (NRS)
Periodo de tiempo: Baseline and post-intervention (4-8 weeks).
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Change in pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate greater pain intensity.
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Baseline and post-intervention (4-8 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)
Periodo de tiempo: Baseline and post-intervention (4-8 weeks).
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Change in diabetes self-efficacy measured using the Diabetes Self-Efficacy Scale (DSES).
The scale consists of 8 items assessing patients' confidence in managing diabetes-related self-care behaviors.
Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident).
Total scores range from 8 to 40, with higher scores indicating higher self-efficacy.
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Baseline and post-intervention (4-8 weeks).
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)
Periodo de tiempo: Baseline and post-intervention (4-8 weeks).
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Change in foot self-care behaviors measured using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En).
The instrument is a validated 16-item self-report questionnaire developed to assess self-care behaviors among patients with diabetes.
It includes three domains: foot self-care, self-examination, and footwear/sock management.
Items are rated on a Likert scale, and higher scores indicate poorer foot self-care behaviors.
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Baseline and post-intervention (4-8 weeks).
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Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
Periodo de tiempo: Baseline and post-intervention (4-8 weeks).
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Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems.
The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life.
Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
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Baseline and post-intervention (4-8 weeks).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jawad AHMAD Ahmed, Asst.Prof.Dr, Jerash University, Faculty of Nursing
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
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Diabetes mellitus
- Angiopatías diabéticas
- Complicaciones de la diabetes
- Enfermedades de la piel
- Úlcera de la piel
- Úlcera en la pierna
- Neuropatías diabéticas
- Úlcera del pie
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Dolor
- Pie diabético
Otros números de identificación del estudio
- DF-EDU-RCT-2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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