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Overactive Bladder Education

NCT02505607 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2015-12-31

No results posted yet for this study

Summary

Overactive bladder (OAB) is a common, chronic condition, characterized by urinary "urgency, with or without urge incontinence, usually with frequency and nocturia." Treatment adherence is a major barrier to management of OAB and drug continuation is poor. Many factors may play a role in non-adherence to medication management of OAB including drug cost, side effects, and a lack of understanding of the disease and treatment process.Studies show that recall of disease information and treatment is often suboptimal. Literature shows that providing written materials is an efficacious way to aid in recall. Based on known poor adherence to OAB medication treatment and the clear role patient education methods have on patient information recall, the investigators believe that improvement of participant education through use of a OAB care plan will improve participant understanding and treatment adherence.

Through this randomized trial, the investigators plan to evaluate whether implementation of a OAB Care Plan improves understanding of disease and treatment options, treatment success, and satisfaction.

This is a prospective, randomized, controlled study of OAB counseling in new patients presenting to the Urogynecology offices of Hartford Hospital. All new patients with a diagnosis of OAB will be offered participation. All consenting participants will be randomized 1:1 to one of two groups: 1) Standard Care group or 2) Care Plan group. In the Standard Care group, participants will be counseled as the physician routinely counsels patients about OAB, in the Care Plan group, participants will be counseled a printed "Overactive Bladder Plan of Care" information sheet. At the end of the visit, the participant will complete a Baseline Survey. The Baseline Survey includes basic demographic information, a physician satisfaction survey, and a OAB knowledge survey. The participant will return for follow up as directed by the physician.

At the follow up visit, participants in both groups will complete a Followup Survey. The Followup Survey will be completed before the participant sees the physician. The Followup Survey assesses OAB knowledge.

Eight months after the baseline visit, each participant's chart will be reviewed for final data collection. If a participant progresses to a treatment method where she is satisfied and would like to remain, this will be documented.

Conditions

  • Urinary Bladder, Overactive
  • Urinary Incontinence, Urge

Interventions

OTHER

Overactive Bladder Care Plan counseling

Use of a printed "Overactive Bladder Plan of Care" information sheet.

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505607 on ClinicalTrials.gov