Ostom-i Alert Sensor Quality of Life Validation

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.

Study Overview

• Status: Unknown
• Conditions: Ostomy
• Intervention / Treatment: Device: Ostom-i Alert Sensor

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Larry F Chu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We will be seeking participants from communities of ostomy patients.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Larry F Chu, MD, Stanford School of Medicine

Publications and helpful links

General Publications

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

Helpful Links

• RAND Medical Outcomes Study: 36-Item Short Form

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ANTICIPATED): March 1, 2019
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (ESTIMATE): December 18, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB-32211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO