Ostomy
Conditions
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.
Interventions
DEVICEOstom-i Alert Sensor
Sensor on ostomy bag.
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Countries
United States
Contacts
Primary ContactDara Rouholiman, BS
Outcome results
None listed