Digital Based Home Care Service for Ostomy Patients

Официальное название

Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials

Обзор

This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on patients' quality of life.

Подробное описание

This study will include patients who have undergone colorectal cancer surgery and received either a colostomy or ileostomy, provided they are comfortable using digital devices like smartphones. Patients will be randomly assigned to either the intervention group, receiving stoma care through a smartphone application, or the conventional group, receiving standard outpatient-based care. The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The app provides patients with information on diet, physical activity, stoma care, emotional support, and daily living needs. Both groups will be assessed for outcomes at the time of enrollment, and at 1 and 6 months. Outcome measures include stoma-related complications such as peristomal dermatitis, dehydration, acute renal failure, readmission due to stoma-related issues, and quality of life and emotional state assessments using EQ-5D-5L and Stoma Quality of Life questionnaires.

Вмешательства

• Поведенческое The Use of a Mobile Application for Stoma Self-Care
  The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The app provides patients with information on diet, physical activity, stoma care, emotional support, and daily living needs.

Первичные конечные точки

• Peristomal Dermatitis [Срок оценки: enrollment, 1 month, and 6 months.]
• Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury [Срок оценки: enrollment, 1 month, and 6 months.]
• Readmission Rate [Срок оценки: enrollment, 1 month, and 6 months.]

Вторичные конечные точки (2)

• Evaluation of Anxiety and Depression [Срок оценки: enrollment, 1 month, and 6 months.]
• Evaluation of Quality of Life [Срок оценки: enrollment, 1 month, and 6 months.]

Критерии участия

Критерии включения

• Patients aged 19 years or older
• Patients who have a colostomy or ileostomy after surgery for colon cancer
• Patients who do not have difficulty using a smartphone

Критерии исключения

• Patients younger than 19 years
• Patients aged 80 years or older
• Patients who do not know how to use a smartphone
• Patients with cognitive impairments
• Patients with pre-existing psychiatric disorders
• Patients who have undergone emergency surgery
• Patients who already have stoma-related complications

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

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06540430 · Ostocare2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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