Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
App group
The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care.
干预措施: The Use of a Mobile Application for Stoma Self-Care (Behavioral)
Conventional group
The control group consists of patients who received conventional outpatient-based stoma care without using the application service.
结局指标
主要结局
Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury
时间窗: enrollment, 1 month, and 6 months.
Incidence rate as a percentage of patients affected.
Readmission Rate
时间窗: enrollment, 1 month, and 6 months.
Incidence rate as the percentage of patients readmitted due to stoma-related complications.
Peristomal Dermatitis
时间窗: enrollment, 1 month, and 6 months.
Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3.
次要结局
- Evaluation of Anxiety and Depression(enrollment, 1 month, and 6 months.)
- Evaluation of Quality of Life(enrollment, 1 month, and 6 months.)