OstomyNCT02472639
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
A study testing Ostom-i Alert Sensor and No Ostom-i Alert Sensor in people with Ostomy, run by Cedars-Sinai Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy
- What is being tested?
- Ostom-i Alert Sensor and No Ostom-i Alert Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2015to 26 May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ileostomies in place without a plan for ileostomy take down in the next 4 months.
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, age 18 and older at the time of study screening;
- Patients with loop or end ileostomy at least 1 month since ileostomy creation
- No plan for stoma reversal for the next 4 months to allow adequate time for study inclusion
- Patients who own an iPhone, iPod Touch, or Android device
Who cannot join
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- Children <18
- Pregnant patients
- Patients with planned ileostomy closure in the next 4 months
- Patients with colostomy, more than one ostomy, or urostomy
- Patients unable or unwilling to come in for in person Ostomi-I Alert teaching and screening visits
- Patients without an iPhone, iPod Touch, or Android device
About this study
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.
Read the 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
- Being tested
- Ostom-i Alert Sensor, No Ostom-i Alert Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostom-i Alert SensorDevice
Wear the Ostom-i Alert Sensor
No Ostom-i Alert SensorOther
Patient will not use device
| Study group | Role | What they receive |
|---|---|---|
| Ostom-i Alert Sensor | Experimental | Patients will wear Ostom-i sensor Receives: Device: Ostom-i Alert Sensor |
| No Ostom-i Alert Sensor | Other | Patient will not wear Ostom-i sensor Receives: Other: No Ostom-i Alert Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 Months
Secondary outcomes (4)
Overall Satisfaction With Ostom-i Device
Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study start10 Jun 2015
- Primary completion26 May 2016
- Study completion26 May 2016
Why it stopped: Patient compliance issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Zaghiyan, Cedars-Sinai Medical Center
- Investigators
- Karen Zaghiyan, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472639
- Sponsor's protocol ID
- Pro00040251
- Status last verified
- Oct 2017
- First submitted
- 12 Jun 2015
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
- ClinicalTrials.gov ID
- NCT02472639
- Acronym / sponsor ID
- Pro00040251
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient compliance issues
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 10 Jun 2015 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Posted 3 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ostom-i Alert Sensor | Experimental | Device: Ostom-i Alert SensorPatients will wear Ostom-i sensor |
| No Ostom-i Alert Sensor | Other | Other: No Ostom-i Alert SensorPatient will not wear Ostom-i sensor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with ileostomies in place without a plan for ileostomy take down in the next 4 months.
- Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- Males or females, age 18 and older at the time of study screening;
- Patients with loop or end ileostomy at least 1 month since ileostomy creation
- No plan for stoma reversal for the next 4 months to allow adequate time for study inclusion
Key exclusion criteria (7 listed)
- Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- Children <18
- Pregnant patients
- Patients with planned ileostomy closure in the next 4 months
- Patients with colostomy, more than one ostomy, or urostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ostom-i Alert SensorWear the Ostom-i Alert Sensor | Device | Ostom-i Alert Sensor |
| No Ostom-i Alert SensorPatient will not use device | Other | No Ostom-i Alert Sensor |
Primary outcome
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
4 secondary outcomes
Overall Satisfaction With Ostom-i Device
Time frame: 3 months
Number of Ostomy Bag Breakages During the Study Period
Time frame: 3 months
Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire
Time frame: 3 months
Dehydration Related Hospital Admissions During Study Period
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Zaghiyan, MD principal investigator
Cedars-Sinai Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ostom-i Alert Sensor and No Ostom-i Alert Sensor in people with Ostomy, run by Cedars-Sinai Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: up to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.