Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02319434
Status:
UNKNOWN
Last Update Posted:
2018-12-07
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ostom-i Alert Sensor Quality of Life Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved quality of life with any ostomy bag', 'timeFrame': '4 weeks', 'description': 'We would like to see if using the sensor improves the quality of life while living with an ostomy bag.'}], 'secondaryOutcomes': [{'measure': 'Self-management (able to manage using and changing their ostomy bag)', 'timeFrame': '4 weeks', 'description': 'Are users better able to manage using and changing their ostomy bag?'}, {'measure': 'Sleep quality (report a higher quality of sleep while using the sensor with their ostomy bag?)', 'timeFrame': '4 weeks', 'description': 'Do participants report a higher quality of sleep while using the sensor with their ostomy bag?'}, {'measure': 'Confidence and self-image (participant report a better self-image and more self-confidence?)', 'timeFrame': '4 weeks', 'description': 'Do participants report a better self-image and more self-confidence with their ostomy bag than before using the sensor?'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ostomy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Burckhardt CS. The Ostomy Adjustment Scale: Further evidence of reliability and validity. Rehabilitation Psychology 35(3): 149-155, 1990.'}, {'pmid': '17196990', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15503840', 'type': 'BACKGROUND', 'citation': 'Grant 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.'}, {'pmid': '29581087', 'type': 'DERIVED', 'citation': 'Rouholiman 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nAn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will be seeking participants from communities of ostomy patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years of age\n* use of an ostomy bag for at least six months\n* must own an iPhone, iPod Touch, or Android\n\nExclusion Criteria:\n\n* use of large urostomy bags'}, 'identificationModule': {'nctId': 'NCT02319434', 'briefTitle': 'Ostom-i Alert Sensor Quality of Life Validation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Validating the Use of a Novel Wearable Device in Improving Quality of Life of Ostomy Patients', 'orgStudyIdInfo': {'id': 'IRB-32211'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ostom-i Alert Sensor', 'type': 'DEVICE', 'description': 'Sensor on ostomy bag.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry F Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Dara Rouholiman, BS', 'role': 'CONTACT', 'email': 'darar@stanford.edu', 'phone': '6507236632'}], 'overallOfficials': [{'name': 'Larry F Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Anesthesiology, Pain, and Perioperative Medicine', 'investigatorFullName': 'Larry Fu-nien Chu', 'investigatorAffiliation': 'Stanford University'}}}}