Ostom-i Alert Sensor Quality of Life Validation



Status:Recruiting
Healthy:No
Age Range:18 - 80
Updated:12/9/2018
Start Date:November 2015
End Date:March 1, 2019
Contact:Dara Rouholiman, BS
Email:darar@stanford.edu
Phone:6507236632

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

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.

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.

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
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Larry F Chu, MD
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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mi
from
Stanford, CA
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