Ostomy Clinical Trial
Official title:
Impact of Ostom-i Alert Sensor on Quality of Life in Patients With Ileostomy
Verified date | October 2017 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 26, 2016 |
Est. primary completion date | May 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | up to 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. | 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. | 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. | 3 months | |
Secondary | Dehydration Related Hospital Admissions During Study Period | Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance. | 3 months |
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