Ostomy
Conditions
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.
Interventions
DEVICEOstom-i Alert Sensor
Wear the Ostom-i Alert Sensor
OTHERNo Ostom-i Alert Sensor
Patient will not use device
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Satisfaction With Ostom-i Device | 3 months | Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. |
| Number of Ostomy Bag Breakages During the Study Period | 3 months | Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. |
| Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire | 3 months | Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. |
| Dehydration Related Hospital Admissions During Study Period | 3 months | Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ostom-i Alert Sensor Patients will wear Ostom-i sensor
Ostom-i Alert Sensor: Wear the Ostom-i Alert Sensor | 0 |
| No Ostom-i Alert Sensor Patient will not wear Ostom-i sensor
No Ostom-i Alert Sensor: Patient will not use device | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 4 | 3 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: up to 3 Months
Population: Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.
Secondary
Dehydration Related Hospital Admissions During Study Period
Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.
Time frame: 3 months
Secondary
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.
Time frame: 3 months
Secondary
Overall Satisfaction With Ostom-i Device
Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.
Time frame: 3 months
Secondary
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.
Time frame: 3 months