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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02319434
Other study ID # IRB-32211
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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