Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Written List
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
Inclusion Criteria:
- New diagnosis of overactive bladder
- post-menopausal
Exclusion Criteria:
- Pre-existing diagnosis of dementia or other cognitive disorders
- Patients with mixed incontinence
- Non-English speaking
- Patients with contraindications to taking vaginal estrogen or anticholinergic medications
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Written list
Control
Arm Description
Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.
Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.
Outcomes
Primary Outcome Measures
Recall
Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02197533
Brief Title
Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
Official Title
Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Overactive bladder (OAB) is a common condition among postmenopausal women, requiring a multifaceted treatment approach that requires patient retention of information given to them in clinic. Recall of recommendations is a key component of compliance. Supplemental educational tools such as handouts and audiovisual information have been investigated for their ability to improve patients' recall of information and increase satisfaction with the clinical encounter.
Objective: To determine if a written list of seven management strategies for overactive bladder leads to improved immediate and delayed recall of these recommendations in postmenopausal women presenting with OAB compared to a traditional verbal discussion.
Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed (2-week) recall of seven OAB management strategies will be compared between two groups. The intervention group will receive a handwritten list during their verbal discussion of OAB treatment while the control group will receive standard care (verbal discussion only). Immediate and delayed recall will be assessed by a member of the study team who has been blinded to participants' group assignments.
Results: The results of this study may guide clinicians in the most effective mode of providing treatment recommendations to post-menopausal patients with OAB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Written list
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.
Intervention Type
Other
Intervention Name(s)
Written List
Intervention Description
Written list of seven management strategies for OAB to be produced during verbal discussion about management.
Primary Outcome Measure Information:
Title
Recall
Description
Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.
Time Frame
0 and 2 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New diagnosis of overactive bladder
post-menopausal
Exclusion Criteria:
Pre-existing diagnosis of dementia or other cognitive disorders
Patients with mixed incontinence
Non-English speaking
Patients with contraindications to taking vaginal estrogen or anticholinergic medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen McDermott, MD, MSc, FRSCS
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions
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