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

July 20, 2017 updated by: Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

910

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2P4
        • University of Alberta
    • Quebec
      • Montreal, Quebec, Canada, H3W1W5
        • Institut Universitaire de Gériatrie de Montréal
  • France
    • Poitou-Charentes
      • Poitiers, Poitou-Charentes, France, 86000
        • Université de Poitiers
  • United Kingdom
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB8 3PH
        • University of Brunel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported improvement in urinary incontinence
Time Frame: 1 year
Patient global impression of improvement questionnaire Sandvik severity index ICIQ-FLUTS
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls
Time Frame: 1 year
Reduction in incontinence-related falls measured by fall diary
1 year
Reduction in incontinence related stigma and quality of life
Time Frame: 1 year
Measured with the Incontinence Quality of Life questionnaire (IQOL)
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Collaborators

Canadian Institutes of Health Research (CIHR)
Medical Research Council
Fonds de la Recherche en Santé du Québec
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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 20, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERA-AGE2 dossier28835

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Continence promotion group education workshop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe