CACTUS-D: Continence Across Continents to Upend Stigma and Dependency

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal (Other)

Overall Status

Completed

CT.gov ID

NCT01858493

Collaborator

Fonds de la Recherche en Santé du Québec (Other), Medical Research Council (Other), Canadian Institutes of Health Research (CIHR) (Other), Institut national de prevention et d'education pour la sante (Other)

910

Enrollment

Locations

Arms

Duration (Months)

227.5

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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

Improved urinary symptoms and quality of life
Reduction in falls
Reduction in stigma

A cost-effectiveness component will also be included

Study Design

Study Type:

Interventional

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 1, 2013

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Self-reported improvement in urinary incontinence [1 year]
Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS

Secondary Outcome Measures

Falls [1 year]
Reduction in incontinence-related falls measured by fall diary
Reduction in incontinence related stigma and quality of life [1 year]
Measured with the Incontinence Quality of Life questionnaire (IQOL)

Other Outcome Measures

Cost-utility of the continence promotion intervention [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 2P4
2	Institut universitaire de gériatrie de Montréal	Montreal	Quebec	Canada	H3W1W5
3	Université de Poitiers	Poitiers	Poitou-Charentes	France	86000
4	University of Brunel	Uxbridge	Middlesex	United Kingdom	UB8 3PH