NCT02319434

Ostom-i Alert Sensor Quality of Life Validation

Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ostomy

Interventions

Type	Name	Description
DEVICE	Ostom-i Alert Sensor	Sensor on ostomy bag.

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2014-12-18
• Last updated: 2018-12-07

Locations

1 site across 1 country: United States