Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT01858493
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2013-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continence Across Continents to Upend Stigma and Dependency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost-utility of the continence promotion intervention', 'timeFrame': '1-year', 'description': 'Cost/QALY. Direct costs will include costs related to the intervention as well as health care resource use due to incontinence-associated falls and health care seeking for incontinence will be measured. Indirect costs will be measured such as the time lost from work for a child or spouse to accompany the participant to receive medical treatment for incontinence or falls. The change in utility from the baseline incontinent condition to improved incontinence with increased social participation and decreased stigma on quality of life will be calculated from SF6D utilities derived from the SF-12 questionnaire at baseline and 1-year follow-up. A disease-specific measure, the IQOL is currently undergoing mapping onto the SF-6D to see if it will provide a more responsive indication of improved quality of life than the generic SF-12 measure.'}], 'primaryOutcomes': [{'measure': 'Self-reported improvement in urinary incontinence', 'timeFrame': '1 year', 'description': 'Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS'}], 'secondaryOutcomes': [{'measure': 'Falls', 'timeFrame': '1 year', 'description': 'Reduction in incontinence-related falls measured by fall diary'}, {'measure': 'Reduction in incontinence related stigma and quality of life', 'timeFrame': '1 year', 'description': 'Measured with the Incontinence Quality of Life questionnaire (IQOL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'Falls', 'Quality of life', 'Stigma', 'Community-dwelling older women', 'Continence promotion'], 'conditions': ['Urinary Incontinence', 'Falls, Accidental', 'Quality of Life', 'Stigma']}, 'referencesModule': {'references': [{'pmid': '23043154', 'type': 'BACKGROUND', 'citation': 'Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5.'}, {'pmid': '24334159', 'type': 'BACKGROUND', 'citation': 'Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.'}, {'pmid': '39360568', 'type': 'DERIVED', 'citation': 'Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.'}, {'pmid': '26652168', 'type': 'DERIVED', 'citation': 'Tannenbaum C, van den Heuvel E, Fritel X, Southall K, Jutai J, Rajabali S, Wagg A. Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial. Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.', 'detailedDescription': 'This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:\n\n1. Improved urinary symptoms and quality of life\n2. Reduction in falls\n3. Reduction in stigma\n\nA cost-effectiveness component will also be included'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* 65 years and older\n* Urinary incontinence at least once weekly\n\nExclusion Criteria:\n\n* Living in residential or long-term care\n* Received treatment for incontinence within the past year\n* Dementia or other neurological conditions that preclude the ability to provide -Informed consent'}, 'identificationModule': {'nctId': 'NCT01858493', 'acronym': 'CACTUS-D', 'briefTitle': 'Continence Across Continents to Upend Stigma and Dependency', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}, 'officialTitle': 'Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence', 'orgStudyIdInfo': {'id': 'ERA-AGE2 dossier28835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continence promotion group education', 'description': 'A single 1-hour continence promotion group education workshop, facilitated by the research coordinator, aimed at changing knowledge and beliefs about urinary incontinence and different treatment options. An evidence-based self-management tool will be distributed at the end of the workshop.', 'interventionNames': ['Behavioral: Continence promotion group education workshop']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham health lecture', 'description': 'A single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia', 'interventionNames': ['Behavioral: Sham health lecture']}], 'interventions': [{'name': 'Continence promotion group education workshop', 'type': 'BEHAVIORAL', 'description': 'Interactive group education workshop promoting continence', 'armGroupLabels': ['Continence promotion group education']}, {'name': 'Sham health lecture', 'type': 'BEHAVIORAL', 'description': 'Interactive group education workshop about general health', 'armGroupLabels': ['Sham health lecture']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2P4', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'H3W1W5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut universitaire de gériatrie de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '86000', 'city': 'Poitiers', 'state': 'Poitou-Charentes', 'country': 'France', 'facility': 'Université de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': 'UB8 3PH', 'city': 'Uxbridge', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'University of Brunel', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}], 'overallOfficials': [{'name': 'Cara Tannenbaum, MD. MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristé de Montréal'}, {'name': 'Adrian Wagg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}, {'name': 'Eleanor van den Heuvel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brunel University'}, {'name': 'Xavier Fritel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Poitiers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': "Institut national de prevention et d'education pour la sante", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cara Tannenbaum', 'investigatorAffiliation': "Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal"}}}}