Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy

The purpose of this study is to evaluate patient satisfaction and quality of life in patients with ileostomy managed with or without the novel Ostom-i Alert device.

Study Overview

• Status: Terminated
• Conditions: Ostomy
• Intervention / Treatment: Device: Ostom-i Alert Sensor; Other: No Ostom-i Alert Sensor

Detailed Description

Patients with ileostomy have impaired quality of life related to their ileostomy (Person et al. DCR. 2012; 55: 783 - 787; Scarpa et al. Colorectal Dis. 2010; 12: 914 - 920). Although patients with ileostomy have better overall quality of life compared with colostomy patients (Silva et al. Worl J Surg. 2003; 27: 421-424), the liquid nature of the ileostomy effluent predisposes these patients to bag overfilling and dehydration more so than colostomy patients (Paquette et al. DCR 2013; 56: 974-979). This may be specifically important in populations with long term or permanent ileostomy. Overfilling and breakage/leakage of the ileostomy bag can also affect patient's ability to function in social environments, go out in public, have intimate relationships with significant others, and interfere with sleep patterns (due to high output and nighttime overfilling of the ileostomy bag).

The Ostom-i Alert is a novel device developed by a patient with ileostomy and now FDA approved in the United States. The device is a sensor that clips onto any ostomy bag and sends a Bluetooth signal to a mobile device app. An alarm lets the patient know before the stoma bag is at risk for overfilling and leaking. The potential advantage is that the device can prevent unexpected bag overfilling, breakage, and nighttime accidents. This may therefore lead to improved quality of life. The volume and output recordings can also be stored and emailed to the patient's health care providers, with potential to reduce ostomy related dehydration through more accurate volume recording and sharing.

While the device has many applications, the purpose of this research study is to specifically evaluate patient quality of life after application of the Ostom-i Alert compared with standard ostomy care.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with ileostomies in place without a plan for ileostomy take down in the next 4 months.
2. Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
3. Males or females, age 18 and older at the time of study screening;
4. Patients with loop or end ileostomy at least 1 month since ileostomy creation
5. No plan for stoma reversal for the next 4 months to allow adequate time for study inclusion
6. Patients who own an iPhone, iPod Touch, or Android device

Exclusion Criteria:

1. Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
2. Children <18
3. Pregnant patients
4. Patients with planned ileostomy closure in the next 4 months
5. Patients with colostomy, more than one ostomy, or urostomy
6. Patients unable or unwilling to come in for in person Ostomi-I Alert teaching and screening visits
7. Patients without an iPhone, iPod Touch, or Android device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ostom-i Alert Sensor; Patients will wear Ostom-i sensor	Device: Ostom-i Alert Sensor; Wear the Ostom-i Alert Sensor
Other: No Ostom-i Alert Sensor; Patient will not wear Ostom-i sensor	Other: No Ostom-i Alert Sensor; Patient will not use device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Quality of Life as Measured by the 20-item Stoma-QOL Questionnaire at 1 Month and 3 Month Follow-up After Using the Ostomi-I Alert Versus Standard Stoma Care Without the Ostom-i Alert.	up to 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Satisfaction With Ostom-i Device	Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.	3 months
Number of Ostomy Bag Breakages During the Study Period	Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.	3 months
Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire	Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.	3 months
Dehydration Related Hospital Admissions During Study Period	Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.	3 months

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Karen Zaghiyan, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2015
• Primary Completion (Actual): May 26, 2016
• Study Completion (Actual): May 26, 2016

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PRO00040251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No