Clinical trial NCT02319434: Ostom-i Alert Sensor Quality of Life Validation
Official title: Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ostomy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be seeking participants from communities of ostomy patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improved quality of life with any ostomy bag
timeFrame: 4 weeks
Secondary outcomes:
measure: Self-management (able to manage using and changing their ostomy bag)
timeFrame: 4 weeks
measure: Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)
timeFrame: 4 weeks
measure: Confidence and self-image (participant report a better self-image and more self-confidence?)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Larry F Chu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology 35(3): 149-155, 1990.
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. doi: 10.1016/j.jss.2006.04.033. Epub 2006 Dec 29.
citation: 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. doi: 10.1023/B:QURE.0000040784.65830.9f.
citation: Rouholiman D, Gamble JG, Dobrota SD, Encisco EM, Shah AG, Grajales Iii FJ, Chu LF. Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study. JMIR Res Protoc. 2018 Mar 26;7(3):e82. doi: 10.2196/resprot.7470.