Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improved quality of life with any ostomy bag
研究概览
简要总结
The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.
详细描述
Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse).
An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •use of an ostomy bag for at least six months
- •must own an iPhone, iPod Touch, or Android
排除标准
- •use of large urostomy bags
结局指标
主要结局
Improved quality of life with any ostomy bag
时间窗: 4 weeks
We would like to see if using the sensor improves the quality of life while living with an ostomy bag.
次要结局
- Self-management (able to manage using and changing their ostomy bag)(4 weeks)
- Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)(4 weeks)
- Confidence and self-image (participant report a better self-image and more self-confidence?)(4 weeks)
研究者
Larry Fu-nien Chu
Associate Professor, Department of Anesthesiology, Pain, and Perioperative Medicine
Stanford University