Patient recruitment will occur at the Stanford University Medical Center. Data analysis and all other matters related to manuscript drafting will occur at the Stanford University School of Medicine. Both settings are located in Palo Alto, California within Santa Clara County.

Recruited patients will be required to meet the eligibility criteria outlined in Textbox 1. Any participants who do not meet our inclusion criteria will be excluded from the study. Our decision to exclude participants who have had an ostomy for less than 6 months was based off the work of Husain and Cataldo [6], who determined that 93% of ostomy-related complications occur within the first six months after ostomy surgery. Furthermore, they determined that psychological adjustment to the ostomy occurs 6 to 10 weeks after surgery, implying that participants in our population will be fully psychologically adjusted to their ostomy [6]. We are limiting our study to patients with colostomy, ileostomy or urostomy. Large urostomy bags will not work with the Ostom-i sensor and thus individuals with large urostomy bags (>9 cm) will be excluded from the study (see Textbox 1 for a complete list of patient inclusion and exclusion criteria).

Participants will be recruited from the Stanford University Medical Center via word of mouth, online advertisements, flyers posted in the hospital as well as referrals from ostomy physicians and nursing staff. Patient recruitment will be facilitated with the help of a number of ostomy nurses at Stanford. Persons interested in the study will be directed to a Web page which includes information about the study sensor, what study participation involves, and a link to a complete online eligibility survey. Participants will not receive monetary compensation for participating in this study, but will be able to keep the Ostom-i sensor which retails for US $125.

Participant screening will occur either online via the Web page, in person, or over the phone. The online screening survey will use Stanford Medicine Qualtrics to collect and analyze data on eligible persons [17].

Patients will serve in both the control and interventional arms of this cross-over pilot study. A cross-over design is advantageous for this pilot study as it allows patients to serve as their own control, therefore variances attributable to confounding factors [18,19]. Once eligibility is confirmed, consent will be obtained and the baseline survey will be given (CoH-QOL-Ostomy, SF-36 and OAS-SF2). After completion of the baseline survey, the participant will be given their Ostom-i alert sensor along with a video tutorial which explains how to use the device.

Once completing the baseline survey, patients will enter the intervention arm of the study where they will receive an Ostom-i sensor which they will use over the course of 4 weeks. Two and 4 weeks after receiving the sensor, primary and secondary outcome measures will be assessed. The Ostom-i is a flexible, Bluetooth-linked sensor that attaches to the patient’s ostomy bag. The sensor portion of the Ostom-i device is a flexible potentiometer produced by Spectra Symbol [20]. The sensor determines the level of the ostomy bag based on the angle of flex it experiences and automatically adjusts when the user is laying down or standing up. The sensor can be adjusted in size from 7 cm to 9 cm to fit a variety of ostomy bag sizes. Data collected by the sensor is sent via Bluetooth to the user’s iOS or Android device and provides alerts informing the wearer of the level of their ostomy bag (Figure 1 and 2).

Participants will retake all 3 surveys after 2 and 4 weeks of device use as previous validation studies of these surveys have used 2-4 week intervals [16,21]. Following completion of the week 4, survey participant involvement in the study will end (see Figure 3 for the study flowchart). Participants will have the option to take the week 2 and week 4 surveys either in person at the hospital or at home, using a paper-based or online format.

The modified CoH-QOL-Ostomy is an ostomy-specific, health-related quality of life instrument with four dimensions. The four dimensions—physical, psychological, social, and spiritual well-being are defined in Table 1. Ostomy-specific, health-related quality of life is calculated by summing scores for each question then dividing by the total number of questions (ie, 43 questions). Total scores for each of the four dimensions are calculated by adding scores on all dimension items and dividing by total number of dimension items. Ostomy-specific, health-related quality of life will be measured at baseline prior to receiving the Ostom-i device, then again after 2 and 4 weeks of device use.

Two secondary outcome measures will be utilized including the SF-36 and the OAS-SF2. The SF-36 is a commonly used general health-related quality of life instrument. In this study, it will be used to compare ostomy-specific, health related quality of life to general (nonostomy-specific) health-related quality of life. The OAS-SF2 is used to examine subjective response to ostomy as well as psychological adjustment to the ostomy.

Our null hypothesis states that there will be no improvement in ostomy-specific, health-related quality of life as measured by the CoH-QOL-Ostomy, compared to baseline measurements prior to sensor use. To calculate the desired sample size to test our null hypothesis, the following paired t-test formula was used:

where our mean and variance is based on the work of Gemmill et al [22], who examined 307 ostomy patients and reported a mean of 8.0 (SD 1.7) for the social well-being dimension within the CoH-QOL-Ostomy, with 80% power and 95% confidence [22]. Our sample size calculation (n=16 for a 15% difference in the dimension of social well-being) was again based on Gemmill et al [22], who reported social well-being to have a higher mean (8.0) than overall quality of life (mean 7.7).

Furthermore, Gemmill et al [22] report a lower SD for the dimension of social well-being (SD 1.7) as compared to physical well-being (SD 1.8), psychological well-being (SD 1.9), and spiritual well-being (SD 2.3). Thus, we chose to base our sample size calculation on the dimension of social well-being. With a sample size calculation of n=4 for 30% difference, we are concerned that our results would lack generalizability. Therefore, by increasing our sample size to 20, we hope that our results will be more generalizable and may help account for a potential 20% attrition rate during recruitment (Table 2).

Our primary outcome, change in ostomy-specific, health-related quality of life from baseline, will be measured using the modified CoH-QOL-Ostomy. This survey was designed and studied for reliability and validity by Grant et al [14] with an overall questionnaire alpha of .95, suggesting strong consistency. The survey can be divided into 6 sections: 1) social adjustment to ostomy (coefficient alpha=.90, correlation to single quality of life item: r=.44, P>.001); 2) general quality of psychological well-being (coefficient alpha=.83, correlation to single quality of life item: r=.76, P>.001); 3) general quality of physical well-being (coefficient alpha=.88, correlation to single quality of life item: r=.39, P>.001); 4) disease-specific effects on physical well-being (coefficient alpha=.77, correlation to single quality of life item: r=.24, P>.001); 5) general quality of spiritual well-being (coefficient alpha=.81, correlation to single quality of life item: r=.51, P>.001); and 6) disease specific effects on psychological well-being (coefficient alpha=.82, correlation to single quality of life item: r=.38, P>.001) [14]. This validated survey has successfully been used by number of studies examining ostomy-related quality of life [22-27].

Our secondary outcomes, general health-related quality of life and psychological adjustment to the ostomy, will be measured using the SF-36 and the OAS-SF2. The SF-36 involves a scale which measures 8 health profiles including physical functioning (PF), role limitations due to physical health problems (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). The SF-36 also yields physical and mental health summary measures and is scored using a Likert scale [28]. Furthermore, the SF-36 has been validated and was found to be reliable across a diverse group of patients with various physical and psychological issues [28,29]. Each of the 8 dimensions of the SF-36 have been found to have a Cronbach alpha statistic greater than the minimum standard of .70; PF (alpha=.90), SF (alpha=.76), RP (alpha=.88), RE alpha=.80), MH (alpha=.83), VT (alpha=.85), GH (alpha=.78), and BP (alpha=.82) suggesting strong internal-consistency and reliability [28,30,31].

Adjustment to ostomy will be evaluated using OAS-SF2 [16]. The OAS is a subjective scale specific to persons with an ostomy, and examines social, psychological, and sexual functioning adjustment to living with an ostomy. The OAS is measured on a 6-point Likert scale and contains 34 items. Cronbach’s alpha for the scale was calculated at alpha=.85 with a test-retest reliability at r=.72 and later confirmed in studies of Swedish, Norwegian, and Chinese patients with an ostomy [32-34]. Two, 17-question short forms (short form 1 and short form 2) were created by Olbrisch based on the original 34 questions. It was determined that each short form could be used independently without compromising reliability or validity of the 34-question-long form (r=.96). Furthermore, short form test-retest consistency and reliability was determined to be r=.69 [21].

Survey assessments will be collected via Stanford Qualtrics (Qualtrics, Provo, UT) survey or pen-and-paper [17]. Data will be entered into the Stanford Research Electronic Data Capture (REDCap) databases (Vanderbilt, Nashville, TN) [35]. All data will be entered and de-identified by trained staff and undergo data quality and accuracy checks.

Data will be presented as mean (SD). Changes between pre- and postintervention quality of life will be assessed using a dependent participant’s paired t-test with 95% confidence interval. Depending on participant retention throughout the course of the study, we may choose to use mixed model regression analysis which would allow us to incorporate incomplete data sets from participants who might not complete the study. Furthermore, we also may choose to use repeated measures analysis of variance to examine differences in population mean scores over the 3 study sessions.

A data monitoring committee (DMC) will not be used in this study. In accordance with the United States Food and Drug Administration Title 21 (21 Code of Federal Regulation 812) and the Stanford University Institutional Review Board (IRB), the Ostom-i alert sensor was not deemed to pose a significant risk to study participants [36]. Furthermore, there is an overall low level of concern for patient safety with the Ostom-i alert sensor. Given the short timeframe of the study, a DMC may not be practical and it is not likely that a DMC will aid in improving the scientific validity of this study [37]. This study is in full compliance with the guidelines outlined by ClinicalTrials.gov.

Due to the minimal intervention in this study, participants are at very low risk for adverse events. Should any adverse events occur, they will be systematically logged and reported to ClinicalTrials.gov. Adverse events involving the ostomy site or the ostomy bag, which are not related to the Ostom-i alert sensor, will be directed to the study participant’s gastroenterologist.

This study is being conducted independently from the Ostom-i alert sensor parent company, 11 Health and Technologies, LLC. 11 Health and Technologies, LLC will not audit any aspect of the study. Due to the short duration of this study (12 months), auditing is not deemed a necessary component of our protocol.

Ethical approval was obtained from the IRB at Stanford University (Protocol #32211). Any amendments made to the study protocol will be immediately reported to the IRB at Stanford University as well as to ClinicalTrials.gov.

Informed consent will be obtained from study participants by study research personnel prior to in-person baseline evaluation. Phone conversations and in-person visits will take place in a private room to protect patient privacy. Data collected by the Ostom-i alert sensor will remain on the participant’s personal device (iPhone, Android, tablet etc) for the duration of the study. Meetings and phone calls will not be recorded and will only involve necessary study staff.

Data collected from participants will include demographic information such as names, telephone numbers, addresses, birthdates, email addresses, illness/diagnosis, gender, age, height, weight, ethnicity, marital status, records of waste output as measured by the Ostom-i alert sensor as well as results from the CoH-QOL-Ostomy, SF-36, and Olbrisch’s Ostomy Adjustment Scale. Demographic and survey data will be collected and stored in a secure database on an encrypted computer.

Participants will be assigned a random, 2-digit numerical identifier which will be stored in a locked safe in the laboratory. Collected data will also be stored in the secure REDCap database and necessary data transfer will occur using secure methods (eg, emails marked as secure). All aspects of data security in this study are in full compliance with the Stanford University Office of Audit, Compliance, Risk and Privacy.

Final trial data will only be available to study research personnel. All necessary demographic and results data will be uploaded to ClinicalTrials.gov in accordance with their rules and regulations.

Should study staff identify health issues in participants over the course of the study, they will be immediately referred to their primary care physician or gastroenterologist. Furthermore, study physicians will be available to answer study participant questions. No poststudy follow-up of participants will occur.

The study authors plan to publish collected data in a peer-reviewed journal (to be determined at a later date). Furthermore, this study is fully compliant with the guidelines set forth by ClinicalTrials.gov and as such all necessary information will be made available in a timely manner. All listed authors and/or contributors are compliant with guidelines outlined by the International Committee of Medical Journal Editors for author inclusion in a published work. Public access to the study protocol and other necessary aspects will be made available through our ClinicalTrials.gov identifier (NCT02319434).