Overactive Bladder Education
Primary Purpose
Urinary Bladder, Overactive, Urinary Incontinence, Urge
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Overactive Bladder Care Plan counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Bladder, Overactive
Eligibility Criteria
Inclusion Criteria:
- diagnosis of overactive bladder
- able and willing to participate and consent
- age >17 years, <90 years
- female sex
Exclusion Criteria:
- male sex
- patients who do not have a diagnosis of overactive bladder
- age <18 years, >89 years
- unable or unwilling to participate
- patients who are already being treated for overactive bladder
- patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder
- patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder
- pregnancy
Sites / Locations
- Hartford Hospital, Urogynecology Division
- Hartford Hospital, Urogynecology Division
- Hartford Hospital, Urogynecology Division
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care Group
Care Plan Group
Arm Description
In this group, subjects will receive standard counseling regarding Overactive Bladder.
In this group, subjects will receive counseling regarding Overactive Bladder using a printed "Overactive Bladder Plan of Care" information sheet.
Outcomes
Primary Outcome Measures
Understanding of Overactive Bladder questionnaire
Secondary Outcome Measures
Subject satisfaction questionnaire
Treatment success chart review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02505607
Brief Title
Overactive Bladder Education
Official Title
Overactive Bladder Education
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
feasibility issues
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive, Urinary Incontinence, Urge
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care Group
Arm Type
No Intervention
Arm Description
In this group, subjects will receive standard counseling regarding Overactive Bladder.
Arm Title
Care Plan Group
Arm Type
Experimental
Arm Description
In this group, subjects will receive counseling regarding Overactive Bladder using a printed "Overactive Bladder Plan of Care" information sheet.
Intervention Type
Other
Intervention Name(s)
Overactive Bladder Care Plan counseling
Intervention Description
Use of a printed "Overactive Bladder Plan of Care" information sheet.
Primary Outcome Measure Information:
Title
Understanding of Overactive Bladder questionnaire
Time Frame
Change from baseline knowledge at follow up visit (on average 8 weeks)
Secondary Outcome Measure Information:
Title
Subject satisfaction questionnaire
Time Frame
Baseline visit (time 0)
Title
Treatment success chart review
Time Frame
8 months after baseline visit
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of overactive bladder
able and willing to participate and consent
age >17 years, <90 years
female sex
Exclusion Criteria:
male sex
patients who do not have a diagnosis of overactive bladder
age <18 years, >89 years
unable or unwilling to participate
patients who are already being treated for overactive bladder
patients who are planning surgical intervention for pelvic organ prolapse prior to treatment of overactive bladder
patients who are planning surgical intervention for stress urinary incontinence prior to treatment of overactive bladder
pregnancy
Facility Information:
Facility Name
Hartford Hospital, Urogynecology Division
City
Glastonbury
State/Province
Connecticut
Country
United States
Facility Name
Hartford Hospital, Urogynecology Division
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Hartford Hospital, Urogynecology Division
City
West Hartford
State/Province
Connecticut
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12559262
Citation
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-Committee of the International Continence Society. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003 Jan;61(1):37-49. doi: 10.1016/s0090-4295(02)02243-4. No abstract available.
Results Reference
background
PubMed Identifier
18439051
Citation
D'Souza AO, Smith MJ, Miller LA, Doyle J, Ariely R. Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008 Apr;14(3):291-301. doi: 10.18553/jmcp.2008.14.3.291.
Results Reference
background
PubMed Identifier
19954264
Citation
Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. doi: 10.18553/jmcp.2009.15.9.728.
Results Reference
background
PubMed Identifier
15744452
Citation
Pickney CS, Arnason JA. Correlation between patient recall of bone densitometry results and subsequent treatment adherence. Osteoporos Int. 2005 Sep;16(9):1156-60. doi: 10.1007/s00198-004-1818-8. Epub 2005 Mar 3.
Results Reference
background
PubMed Identifier
19531618
Citation
Watson PW, McKinstry B. A systematic review of interventions to improve recall of medical advice in healthcare consultations. J R Soc Med. 2009 Jun;102(6):235-43. doi: 10.1258/jrsm.2009.090013.
Results Reference
background
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Overactive Bladder Education
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