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Clinical Trials/NCT03485872
NCT03485872CompletedNot Applicable

Urinary Incontinence Self-Screening for Healthy Aging

University of British Columbia1 site in 1 country53 target enrollmentStarted: March 11, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53
Locations
1
Primary Endpoint
Self-Referral Questionnaire

Study Overview

Brief Summary

The purpose of this study is to increase awareness and timely treatment of urinary incontinence through a self-screening process. This is a 3 month study involving 2 activities; one taking place at the beginning of study and another 3 months later. Participants will be randomized into experimental and control groups. The experimental group will receive a demographic questionnaire, quality of life questionnaire, a questionnaire pertaining to urinary symptoms, information about how to self-screen for urinary incontinence and information regarding how to refer oneself to urinary incontinence resources. The control group will receive the demographic and quality of life questionnaires only. It is estimated that it will take participants 20-30 minutes to complete their package of questionnaires. After 3 months, the participants will receive a phone call inquiring into what actions they have taken regarding their urinary incontinence.

Detailed Description

Objectives: The overall aim is to increase awareness of urinary incontinence in community-based older adults and promote timely treatment. To achieve this aim the project objectives will include:

  1. To develop a self-screening process for community-based older adults
  2. To test the use of a self-screening process with community-based older adults

Methods:

Study Design: This study will use a pilot randomized control trial to test the effectiveness of a self-screening process with older adults. The hypothesis is that older adults exposed to the self-screening process will follow up with health professionals to receive help for the UI condition. There will be two groups of older adults. The intervention group will participate in self-screening and the control will not be exposed to self-screening. Using this approach is necessary to determine whether or not the self-screening works.

Setting: Senior's Centers and organizations dedicated to seniors in Kelowna, West Kelowna and Lake Country will serve as the recruitment sites for this study. These Senior's Centers/organizations (e.g., Lake Country Seniors Centre, Lake Country Health Planning Society, Westside Health Network, Seniors Outreach Bureau) serve large and different populations of seniors (>300 seniors) so overlap in membership is not expected to be an issue. Excel randomization function will be used to assign participants to one of the two arms (the arm receiving the self-screening process or the arm not receiving this process). The randomization assignments (allocations) will be placed in individual sealed envelopes. After informed consent is obtained, the Research Assistant (RA) will choose the next available envelope to reveal which arm the study participant will be assigned.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adults 65 years of age and older
  • •Attend a local Senior's Centre or organization
  • •Report having some UI symptoms
  • •Living independently
  • •Ambulatory
  • •No more than mild cognitive impairment
  • •Able to read and write in English or have someone who can assist with reading the data collection information and can complete a paper survey independently

Exclusion Criteria

  • •Cognitive impairment
  • •Require more than minimal assistance with completing the survey
  • •Any impairment (e.g., vision) that would make self-screening and follow up challenging.
  • •Have been referred to a UI specialist or continence program in the past

Arms & Interventions

Self-Screening and Referral Information

Experimental

The intervention will include a combination of self-screening and UI specific information and resources. Older adults in the intervention group will complete a gender specific UI Self-Screening tool. Men will complete the International Consultation on Incontinence Modular Questionnaire (ICIQ) for Males and women will complete the ICIQ for Females. In addition, the intervention group will receive a fact sheet with UI specific information, contact information to the local incontinence clinic and a link to a website with patient incontinence resources and education.

Intervention: Self-Screening and Referral Information (Other)

Control Group

Active Comparator

Older adults assigned to the control group will receive standard care from their physicians. Standard care may differ from general practitioner to general practitioner. Usual care for urinary incontinence (UI) from general practitioners is generally minimal. Most patients do not tell their physicians about UI, and most physicians do not ask about UI. If this topic does come up during a GP appointment, a patient may be offered no treatment, lifestyle advice (e.g., do not drink before bed), told to do Kegels (but likely not instructed how to do these properly) or in some cases, offered pharmacological therapies (which will be captured in our questionnaire with the participants). But standard of care is unfortunately very often no care.

Intervention: Standard Care (Other)

Outcomes

Primary Outcomes

Self-Referral Questionnaire

Time Frame: 3 months

The primary outcome will be the number of older adults who take action to receive help for their UI. The following question will be asked through a questionnaire at three month follow-up: "During the past three months, what have you done about the leakage?" Participants will have the option to check off any of the following options: "I haven't done anything about it", "have seen my GP about it", and "referred myself to the local Urinary Incontinence Clinic".

Secondary Outcomes

  • Treatments Received Questionnaire(3 months)
  • Satisfaction with Care Questionnaire(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kathy Rush

Associate Professor

University of British Columbia

Study Sites (1)

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