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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- Номер телефона: +962779084560
- Электронная почта: JAWAD_0799@YAHOO.COM
Места учебы
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-
Dours
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Jerash, Dours, Иордания, 009627
- Ministry of Health Primary Healthcare Centers
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Контакт:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
- Номер телефона: 0779084560
- Электронная почта: JAWAD_0799@YAHOO.COM
-
Контакт:
- Электронная почта: JAWAD_0799@YAHOO.COM
-
Главный следователь:
- Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Контрольная группа
|
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.
|
|
Экспериментальный: Educational Program Group
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pain Intensity Measured Using the Numeric Rating Scale (NRS)
Временное ограничение: Baseline and post-intervention (4-8 weeks).
|
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.
|
Baseline and post-intervention (4-8 weeks).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)
Временное ограничение: Baseline and post-intervention (4-8 weeks).
|
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.
|
Baseline and post-intervention (4-8 weeks).
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)
Временное ограничение: Baseline and post-intervention (4-8 weeks).
|
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
Временное ограничение: Baseline and post-intervention (4-8 weeks).
|
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).
|
Baseline and post-intervention (4-8 weeks).
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Jawad AHMAD Ahmed, Asst.Prof.Dr, Jerash University, Faculty of Nursing
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания эндокринной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Сахарный диабет
- Диабетические ангиопатии
- Осложнения диабета
- Кожные заболевания
- Язва кожи
- Язва на ноге
- Диабетические невропатии
- Язва стопы
- Патологические состояния, признаки и симптомы
- Заболевания кожи и соединительной ткани
- Признаки и симптомы
- Боль
- Диабетическая стопа
Другие идентификационные номера исследования
- DF-EDU-RCT-2026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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