Study Stopped
Patient compliance issues
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
1 other identifier
interventional
7
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2015
CompletedFirst Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2016
CompletedResults Posted
Study results publicly available
October 3, 2017
CompletedNovember 9, 2017
October 1, 2017
12 months
June 12, 2015
September 8, 2017
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall Satisfaction With Ostom-i Device
3 months
Number of Ostomy Bag Breakages During the Study Period
3 months
Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire
3 months
Dehydration Related Hospital Admissions During Study Period
3 months
Study Arms (2)
Ostom-i Alert Sensor
EXPERIMENTALPatients will wear Ostom-i sensor
No Ostom-i Alert Sensor
OTHERPatient will not wear Ostom-i sensor
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Patients who own an iPhone, iPod Touch, or Android device
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Limitations and Caveats
Study only accrued 7 patients. Due to non-compliance and issues with the device it was decided to terminate the study. No data analysis has been done and will not be done in the future. This study was been closed with the IRB.
Results Point of Contact
- Title
- Karen Zaghiyan, MD
- Organization
- Cedars Sinai Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Zaghiyan, MD
Cedars-Sinai Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Colon & Rectal Surgeon
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 16, 2015
Study Start
June 10, 2015
Primary Completion
May 26, 2016
Study Completion
May 26, 2016
Last Updated
November 9, 2017
Results First Posted
October 3, 2017
Record last verified: 2017-10