Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women

This study has been completed.
Sponsor:
Collaborators:
Brunel University
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier:
NCT01239836
First received: November 10, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

Urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. The aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. The main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.


Condition Intervention
Urinary Incontinence
Behavioral: Constructivist interactive workshop on urinary incontinence
Behavioral: Evidence-based self-management tool
Behavioral: General health lecture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Self-management, Constructivism or Both as Knowledge Transfer Strategies for Reducing the Cost and Impact of Urinary Incontinence Among Community-dwelling Senior Women in the United Kingdom

Resource links provided by NLM:


Further study details as provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:

Primary Outcome Measures:
  • Incontinence frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reductions in incontinence frequency as indicated on a 72-hour voiding diary at 3-months post-intervention compared to baseline.


Secondary Outcome Measures:
  • Cost of pad use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Reductions in the cost of pad use per day at 3-months post intervention compared to baseline.

  • Self-efficacy for managing incontinence [ Time Frame: 3-months ] [ Designated as safety issue: No ]
    An increase of 5 points or more on the Geriatric Self-Efficacy index for urinary incontinence at 3-months post-intervention compared to baseline.


Enrollment: 259
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-management Behavioral: Evidence-based self-management tool
Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.
Sham Comparator: General Health Lecture Behavioral: General health lecture
Participants will attend a lecture on general women`s health issues that does not address urinary incontinence.
Experimental: Combined workshop and self-management Behavioral: Constructivist interactive workshop on urinary incontinence
A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.
Behavioral: Evidence-based self-management tool
Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.
Experimental: Workshop Behavioral: Constructivist interactive workshop on urinary incontinence
A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.

Detailed Description:

The research design is a 2x2 factorial open-label cluster randomised controlled trial. The cluster (unit of randomization) is at the level of each local community senior's group, from whence participants will be recruited. Incontinent community-dwelling older women aged 60 years and older who have not sought care for their urinary symptoms in the last two years, but who experience incontinence at least twice weekly will be recruited through local community organizations. Eligible participants from each local community centre will be randomly assigned as a group to one of four interventions. The first intervention is participation in an interactive constructivist continence workshop. The second intervention involves receipt of an evidence-based self-management tool for incontinence. The third group will receive both interventions. The fourth group will act as the control group: they will simply be asked about their urinary symptoms and given a general talk on women's health. At the end of the study, the control group will be offered the self-management tool.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 60 years or older
  • Urinary incontinence twice weekly
  • Women who have not sought medical advice for incontinence symptoms in the last 2 years.
  • Fluent in English

Exclusion Criteria:

  • Women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence).
  • Women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment.
  • Women with a history of a neurological condition (e.g. Multiple Sclerosis and spinal cord injury) because they require further investigation. Women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation.
  • Women who do not consent to participate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239836

Locations
United Kingdom
Brunel University
Uxbridge, Middlesex, United Kingdom, UB8 3PH
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Brunel University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Cara Tannenbaum, MD Centre de recherche de l'Institut universitaire de gériatrie de Montréal
Study Director: Eleanor van den Heuvel, PhD Brunel University
  More Information

Publications:
Responsible Party: Cara Tannenbaum, Dr., Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT01239836     History of Changes
Other Study ID Numbers: CIHR-200909-CUK-202417
Study First Received: November 10, 2010
Last Updated: May 14, 2013
Health Authority: United Kingdom: Brunel University Research Ethics Committee

Keywords provided by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
urinary incontinence, self-management, cost, self-efficacy, continence promotion

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014