Ostom-i Alert Sensor Quality of Life Validation

NCT02319434 | Unknown

• 1 other identifier: IRB-32211
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self-management (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?)

  4 weeks

• Confidence and self-image (participant report a better self-image and more self-confidence?)

  4 weeks

Interventions

Ostom-i Alert Sensor DEVICE

Sensor on ostomy bag.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will be seeking participants from communities of ostomy patients.

You may qualify if:

• years of age
• use of an ostomy bag for at least six months
• must own an iPhone, iPod Touch, or Android

You may not qualify if:

• use of large urostomy bags

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (4)

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

  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.

  PMID: 17196990 BACKGROUND

• 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.

  PMID: 15503840 BACKGROUND

• 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.

  PMID: 29581087 DERIVED

Study Officials

• Larry F Chu, MD

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dara Rouholiman, BS

CONTACT

6507236632; darar@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology, Pain, and Perioperative Medicine

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: November 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)