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Ostom-i Alert Sensor Quality of Life Validation

NCT ID: NCT02319434

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-03-01

Brief Summary

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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

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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.

Conditions

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Ostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ostom-i Alert Sensor

Sensor on ostomy bag.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Larry Fu-nien Chu

Associate Professor, Department of Anesthesiology, Pain, and Perioperative Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry F Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford School of Medicine

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dara Rouholiman, BS

Role: CONTACT

Phone: 6507236632

Email: [email protected]

References

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 17196990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15503840 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29581087 (View on PubMed)

Other Identifiers

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IRB-32211

Identifier Type: -

Identifier Source: org_study_id