Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions

NCT ID: NCT02197533

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2019-09-01

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Written list

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.

Group Type: EXPERIMENTAL

Written List

Intervention Type: OTHER

Written list of seven management strategies for OAB to be produced during verbal discussion about management.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Written List

Written list of seven management strategies for OAB to be produced during verbal discussion about management.

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colleen McDermott, MD, MSc, FRSCS

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-213

Identifier Type: -

Identifier Source: org_study_id