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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01858493
Other study ID # ERA-AGE2 dossier28835
Secondary ID
Status Completed
Phase N/A
First received May 14, 2013
Last updated July 20, 2017
Start date May 2013
Est. completion date July 2017

Study information

Verified date July 2017
Source Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 910
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Female
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Continence promotion group education workshop
Interactive group education workshop promoting continence
Sham health lecture
Interactive group education workshop about general health

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada Institut universitaire de gériatrie de Montréal Montreal Quebec
France Université de Poitiers Poitiers Poitou-Charentes
United Kingdom University of Brunel Uxbridge Middlesex

Sponsors (5)

Lead Sponsor Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec, Institut national de prevention et d'education pour la sante, Medical Research Council

Countries where clinical trial is conducted

Canada,  France,  United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Cost-utility of the continence promotion intervention 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. 1-year
Primary Self-reported improvement in urinary incontinence Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS 1 year
Secondary Falls Reduction in incontinence-related falls measured by fall diary 1 year
Secondary Reduction in incontinence related stigma and quality of life Measured with the Incontinence Quality of Life questionnaire (IQOL) 1 year
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