Ostom-i Alert Sensor Quality of Life Validation

Ostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02319434
• Other study ID #: IRB-32211
• Status: Recruiting
• Start date: November 2015
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2018
• Source: Stanford University
• Contact: Dara Rouholiman, BS
• Phone: 6507236632
• Email: darar[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ostomy

Intervention

Device:
• Ostom-i Alert Sensor
Sensor on ostomy bag.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Burckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology 35(3): 149-155, 1990.

Grant M, Ferrell B, Dean G, Uman G, Chu D, Krouse R. Revision and psychometric testing of the City of Hope Quality of Life-Ostomy Questionnaire. Qual Life Res. 2004 Oct;13(8):1445-57. — View Citation

Krouse R, Grant M, Ferrell B, Dean G, Nelson R, Chu D. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res. 2007 Mar;138(1):79-87. Epub 2006 Dec 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved quality of life with any ostomy bag	We would like to see if using the sensor improves the quality of life while living with an ostomy bag.	4 weeks
Secondary	Self-management (able to manage using and changing their ostomy bag)	Are users better able to manage using and changing their ostomy bag?	4 weeks
Secondary	Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)	Do participants report a higher quality of sleep while using the sensor with their ostomy bag?	4 weeks
Secondary	Confidence and self-image (participant report a better self-image and more self-confidence?)	Do participants report a better self-image and more self-confidence with their ostomy bag than before using the sensor?	4 weeks

External Links

•   RAND Medical Outcomes Study: 36-Item Short Form