Ostom-i Alert Sensor Quality of Life Validation

• Conditions: Ostomy

• Registration Number: NCT02319434
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Study Start: 2015-11
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Read More

Exclusion Criteria

• use of large urostomy bags

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved quality of life with any ostomy bag	4 weeks	We would like to see if using the sensor improves the quality of life while living with an ostomy bag.

Secondary Outcome Measures

Name	Time	Method
Self-management (able to manage using and changing their ostomy bag)	4 weeks	Are users better able to manage using and changing their ostomy bag?
Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)	4 weeks	Do participants report a higher quality of sleep while using the sensor with their ostomy bag?
Confidence and self-image (participant report a better self-image and more self-confidence?)	4 weeks	Do participants report a better self-image and more self-confidence with their ostomy bag than before using the sensor?

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States