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Trial record 42 of 696 for:    (elderly OR senior) AND incontinence AND (woman OR women OR female)

Continence Across Continents to Upend Stigma and Dependency (CACTUS-D)

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ClinicalTrials.gov Identifier: NCT01858493
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : July 24, 2017
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Medical Research Council
Canadian Institutes of Health Research (CIHR)
Institut national de prevention et d'education pour la sante
Information provided by (Responsible Party):
Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Falls, Accidental Quality of Life Stigma Behavioral: Continence promotion group education workshop Behavioral: Sham health lecture Not Applicable

Detailed Description:

This is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on:

  1. Improved urinary symptoms and quality of life
  2. Reduction in falls
  3. Reduction in stigma

A cost-effectiveness component will also be included


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 910 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continence promotion group education
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.
Behavioral: Continence promotion group education workshop
Interactive group education workshop promoting continence

Sham Comparator: Sham health lecture
A single 1-hour group education workshop on other health topics of concern to older women such as memory, hearing, insomnia
Behavioral: Sham health lecture
Interactive group education workshop about general health




Primary Outcome Measures :
  1. Self-reported improvement in urinary incontinence [ Time Frame: 1 year ]
    Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS


Secondary Outcome Measures :
  1. Falls [ Time Frame: 1 year ]
    Reduction in incontinence-related falls measured by fall diary

  2. Reduction in incontinence related stigma and quality of life [ Time Frame: 1 year ]
    Measured with the Incontinence Quality of Life questionnaire (IQOL)


Other Outcome Measures:
  1. Cost-utility of the continence promotion intervention [ Time Frame: 1-year ]
    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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • 65 years and older
  • Urinary incontinence at least once weekly

Exclusion Criteria:

  • Living in residential or long-term care
  • Received treatment for incontinence within the past year
  • Dementia or other neurological conditions that preclude the ability to provide -Informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858493


Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2P4
Canada, Quebec
Institut universitaire de gériatrie de Montréal
Montreal, Quebec, Canada, H3W1W5
France
Université de Poitiers
Poitiers, Poitou-Charentes, France, 86000
United Kingdom
University of Brunel
Uxbridge, Middlesex, United Kingdom, UB8 3PH
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Fonds de la Recherche en Santé du Québec
Medical Research Council
Canadian Institutes of Health Research (CIHR)
Institut national de prevention et d'education pour la sante
Investigators
Principal Investigator: Cara Tannenbaum, MD. MSc Univeristé de Montréal
Principal Investigator: Adrian Wagg, MD University of Alberta
Principal Investigator: Eleanor van den Heuvel, PhD Brunel University
Principal Investigator: Xavier Fritel, MD, PhD University of Poitiers

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cara Tannenbaum, Principal Investigator, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01858493     History of Changes
Other Study ID Numbers: ERA-AGE2 dossier28835
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Keywords provided by Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Urinary incontinence
Falls
Quality of life
Stigma
Community-dwelling older women
Continence promotion

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders