Clinical trial NCT02472639: Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
Official title: Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ostomy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 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.
timeFrame: up to 3 Months
Secondary outcomes:
measure: Overall Satisfaction With Ostom-i Device
timeFrame: 3 months
measure: Number of Ostomy Bag Breakages During the Study Period
timeFrame: 3 months
measure: Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire
timeFrame: 3 months
measure: Dehydration Related Hospital Admissions During Study Period
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Karen Zaghiyan, MD
role: PRINCIPAL_INVESTIGATOR
References: