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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Structured Educational Program
  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

Первичные конечные точки

• Pain Intensity Measured Using the Numeric Rating Scale (NRS) [Срок оценки: Baseline and post-intervention (4-8 weeks).]

Вторичные конечные точки (1)

• Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES) [Срок оценки: Baseline and post-intervention (4-8 weeks).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Иордания · 1 центр

• Ministry of Health Primary Healthcare Centers — Jerash

Идентификаторы

NCT: NCT07563751 · DF-EDU-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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