OstomyNCT02319434
Ostom-i Alert Sensor Quality of Life Validation
An observational study of Ostomy, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ostomy
- What is being tested?
- Ostom-i Alert Sensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 1 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will be seeking participants from communities of ostomy patients.
Who may be able to join
- 18-80 years of age
- use of an ostomy bag for at least six months
- must own an iPhone, iPod Touch, or Android
Who cannot join
- use of large urostomy bags
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Larry F Chu, MD
About this study
Official title: Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients
The purpose of this study is to determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.
Read the detailed description
Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse).
An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.
- Conditions
- Ostomy
- Being tested
- 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
Sensor on ostomy bag.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life with any ostomy bag
We would like to see if using the sensor improves the quality of life while living with an ostomy bag.
Measured: 4 weeks
Secondary outcomes (3)
Self-management (able to manage using and changing their ostomy bag)
Are users better able to manage using and changing their ostomy bag?
Measured: 4 weeks
Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)
Do participants report a higher quality of sleep while using the sensor with their ostomy bag?
Measured: 4 weeks
Confidence and self-image (participant report a better self-image and more self-confidence?)
Do participants report a better self-image and more self-confidence with their ostomy bag than before using the sensor?
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startNov 2015
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Fu-nien Chu, Stanford University
- Investigators
- Larry F Chu, MD, Principal investigator, Stanford School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319434
- Sponsor's protocol ID
- IRB-32211
- Status last verified
- Dec 2018
- First submitted
- 15 Dec 2014
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Burckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology 35(3): 149-155, 1990.
Krouse R, Grant M, Ferrell B, Dean G, Nelson R, Chu D. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res. 2007 Mar;138(1):79-87. doi: 10.1016/j.jss.2006.04.033. Epub 2006 Dec 29.
PubMed 17196990Grant M, Ferrell B, Dean G, Uman G, Chu D, Krouse R. Revision and psychometric testing of the City of Hope Quality of Life-Ostomy Questionnaire. Qual Life Res. 2004 Oct;13(8):1445-57. doi: 10.1023/B:QURE.0000040784.65830.9f.
PubMed 15503840Rouholiman D, Gamble JG, Dobrota SD, Encisco EM, Shah AG, Grajales Iii FJ, Chu LF. Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study. JMIR Res Protoc. 2018 Mar 26;7(3):e82. doi: 10.2196/resprot.7470.
PubMed 29581087
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients
- ClinicalTrials.gov ID
- NCT02319434
- Acronym / sponsor ID
- IRB-32211
- Conditions
- Ostomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
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 determine the usability and acceptance of the Ostom-i Alert Sensor. The investigators would like to see if is generally helpful to ostomy patients and whether it has a beneficial impact on living with an ostomy bag. Results from this study will be used to determine if a larger clinical study is feasible.
Detailed description
Evidence from clinical experience shows that patients with ostomies go through a significant life change to learn to live with the ostomy bag. These changes can include "an altered body image, changes in daily routines, and for some, changes in life patterns such as work and leisure activities" (Burckhardt). Previous studies have also shown that ostomy patients have negative changes in their physical, psychological, social, and spiritual quality of life (Krouse).
An ostomy patient developed the Ostom-i Alert Sensor after experiencing these changes - the goal of the sensor is to make life easier for patients with ostomy bags, by allowing for easier output measurements and anticipation of bag changes. In this study, we hope to use this new device and track any improvements for quality of life for ostomy patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will be seeking participants from communities of ostomy patients.
Key inclusion criteria (3 listed)
- 18-80 years of age
- use of an ostomy bag for at least six months
- must own an iPhone, iPod Touch, or Android
Key exclusion criteria (1 listed)
- use of large urostomy bags
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 SensorSensor on ostomy bag. | Device | – |
Primary outcome
Improved quality of life with any ostomy bag
Time frame: 4 weeks
We would like to see if using the sensor improves the quality of life while living with an ostomy bag.
3 secondary outcomes
Self-management (able to manage using and changing their ostomy bag)
Time frame: 4 weeks
Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)
Time frame: 4 weeks
Confidence and self-image (participant report a better self-image and more self-confidence?)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- BackgroundBurckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology 35(3): 149-155, 1990.
- Background: PubMed 17196990Krouse R, Grant M, Ferrell B, Dean G, Nelson R, Chu D. Quality of life outcomes in 599 cancer and non-cancer patients with colostomies. J Surg Res. 2007 Mar;138(1):79-87. doi: 10.1016/j.jss.2006.04.033. Epub 2006 Dec 29.
- Background: PubMed 15503840Grant M, Ferrell B, Dean G, Uman G, Chu D, Krouse R. Revision and psychometric testing of the City of Hope Quality of Life-Ostomy Questionnaire. Qual Life Res. 2004 Oct;13(8):1445-57. doi: 10.1023/B:QURE.0000040784.65830.9f.
- Derived from this study: PubMed 29581087Rouholiman D, Gamble JG, Dobrota SD, Encisco EM, Shah AG, Grajales Iii FJ, Chu LF. Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study. JMIR Res Protoc. 2018 Mar 26;7(3):e82. doi: 10.2196/resprot.7470.
- Individual participant dataSharing planned: No
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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.
Larry F Chu, MD principal investigator
Stanford School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy, run by Stanford University at 1 site in United States.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dara Rouholiman, BS (6507236632, darar@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of life with any ostomy bag (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319434, which also lists 4 linked publications.
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 7 Dec 2018.