Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ostomy
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improved quality of life with any ostomy bag
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Larry Fu-nien Chu
Associate Professor, Department of Anesthesiology, Pain, and Perioperative Medicine
Stanford University
Eligibility Criteria
Inclusion Criteria
- •18-80 years of age
- •use of an ostomy bag for at least six months
- •must own an iPhone, iPod Touch, or Android
Exclusion Criteria
- •use of large urostomy bags
Outcomes
Primary Outcomes
Improved quality of life with any ostomy bag
Time Frame: 4 weeks
We would like to see if using the sensor improves the quality of life while living with an ostomy bag.
Secondary Outcomes
- 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)