Telehealth vs In-person Education for Enhancing Self-care of Ostomy Patients (SELF-STOMA): Study Design of a Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 10
- 主要终点
- Self-care maintenance
研究概览
简要总结
The primary aim of this study is to evaluate whether remote education is as effective as in-person education in improving self-care behaviors of ostomy patients.
详细描述
After signing the informed consent form, patients with ostomy will be assigned to the intervention or active control group (1:1). The intervention group will receive a total of four remote educational sessions over 2 months. The control group will receive the standard care, consisting of in-person standard education.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having undergone a surgical operation with subsequent ostomy placement;
- •being at least 18 years old of age;
- •absence of cognitive decline,
- •absence of any
- •being able to manage the software on the smartphone
- •be willing to participate to the trial and sign the informed consent form.
排除标准
- •presence of a cognitive decline, assessed with a score > 4 at the Six-item Screener
- •presence of any stomal or peristomal complication
- •not being able to read and speak Italian language
结局指标
主要结局
Self-care maintenance
时间窗: 1 month after the last intervention
Self-care maintenance will be measured with the Ostomy Self-care Index (OSCI). Scores range from 0 to 100, with higher scores indicating better self-care maintenance
次要结局
- Adjustment to the stoma(1 month after the last intervention)
- Self-care monitoring(1 month after the last intervention)
- Self-care self-efficacy(1 month after the last intervention)
- Mobility (distance in km from the patient house to the hospital and vice versa, means of transportation used, and presence of a companion)(1 month after the last intervention)
- Stoma-specific quality of life(1 month after the last intervention)
- Self-care management(1 month after the last intervention)
- Depression(1 month after the last intervention)
- Stomal and peristomal complications rates(1 month after the last intervention)
- Health care service utilization(1 month after the last intervention)
研究者
Ercole Vellone
Associate Professor
University of Rome Tor Vergata