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

NCT ID: NCT02472639

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-10
• Study Completion Date: 2016-05-26

Brief Summary

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.

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.

Conditions

Ostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ostom-i Alert Sensor

Patients will wear Ostom-i sensor

Group Type: EXPERIMENTAL

Ostom-i Alert Sensor

Intervention Type: DEVICE

Wear the Ostom-i Alert Sensor

No Ostom-i Alert Sensor

Patient will not wear Ostom-i sensor

Group Type: OTHER

No Ostom-i Alert Sensor

Intervention Type: OTHER

Patient will not use device

Interventions

Ostom-i Alert Sensor

Wear the Ostom-i Alert Sensor

Intervention Type: DEVICE

No Ostom-i Alert Sensor

Patient will not use device

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Karen Zaghiyan

Colon & Rectal Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Zaghiyan, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Other Identifiers

Pro00040251

Identifier Type: -

Identifier Source: org_study_id