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Набор скоро начнётся NCT07074301

Training Program for PEG Caregivers: A Structured Intervention Study

Без фазы С лечением Percutaneous Endoscopic Gastrostomy (PEG) Training Caregiver Burden Nutritional Support

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Caregiver Training Program.
Кому может быть актуально
Состояния в реестре: Percutaneous Endoscopic Gastrostomy (PEG), Training, Caregiver Burden, Nutritional Support. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effectiveness of Education and Mobile Application for Percutaneous Endoscopic Gastrostomy Care

Обзор

This study aims to develop and evaluate a structured education program and a mobile application to support caregivers of patients receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG). The intervention focuses on improving caregivers' knowledge, care practices, and perceived burden. The study will be conducted in three phases: a needs assessment, development of the education and digital support modules, and implementation of the intervention. Quantitative and qualitative data will be collected to evaluate the impact of the intervention. The results are expected to contribute to the improvement of home PEG care quality and the empowerment of caregivers.

Подробное описание

This study is designed to improve the caregiving practices of individuals who are responsible for patients receiving long-term enteral nutrition via percutaneous endoscopic gastrostomy (PEG). The study is structured in three phases: (1) identification of caregivers' needs through descriptive and qualitative assessments, (2) development of a theory-based structured education program and a mobile application, and (3) implementation and evaluation of the intervention using a mixed-methods design.

In the first phase, caregivers' knowledge gaps, challenges, and educational needs will be identified through a needs assessment that includes questionnaires and semi-structured interviews. In the second phase, based on the findings of the initial assessment and supported by current clinical guidelines and national health policies, a structured education program and a digital support tool (mobile app) will be developed. The educational content will cover PEG fundamentals, stoma care, tube cleaning, enteral feeding, medication administration via PEG, complication management, and psychosocial support. Educational materials will include videos, animations, texts, and interactive quizzes, and the mobile app will allow asynchronous learning and monitoring.

In the third phase, the education program will be delivered through in-person theoretical and practical sessions, followed by the use of the mobile application. Outcome measures will include caregivers' knowledge level, caregiving burden, self-reported practices, and satisfaction with the intervention. Quantitative data will be collected using validated measurement tools, and qualitative feedback will be gathered to provide a deeper understanding of the intervention's impact. This study is expected to support the standardization of home PEG care and enhance caregiver capacity through sustainable and scalable educational interventions.

Вмешательства

  • Поведенческое Caregiver Training Program
    The intervention consists of a two-month structured education program including two face-to-face sessions and a mobile application. The training content covers PEG care, stoma and tube management, enteral nutrition, drug administration via tube, and troubleshooting complications.

Первичные конечные точки

  • Change in Caregiver Knowledge Level [Срок оценки: Baseline and monthly assessments during 2-month intervention]
Вторичные конечные точки (4)
  • PEG Problems [Срок оценки: Baseline and monthly assessments during 2-month intervention]
  • Caregiver Burden Perception: [Срок оценки: Baseline and monthly assessments during 2-month intervention]
  • Training and Mobile Application Satisfaction: [Срок оценки: Baseline and monthly assessments during 2-month intervention]
  • Effectiveness of the Cleaning Brush [Срок оценки: Baseline and monthly assessments during 2-month intervention]

Критерии участия

Критерии включения

  • Age 18 or older
  • Willingness to participate voluntarily in the study
  • No communication barriers
  • Ability to use a smartphone
  • No diagnosed psychiatric disorder
  • Providing care to a patient aged 18 or older who is scheduled to undergo PEG placement

Критерии исключения

  • Discharge from hospital or death of the patient during the study period
  • Being under 18 years old
  • Illiteracy of the caregiver

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07074301 · 2024.389.IRB2.171

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗