Overactive Bladder Education

NCT02505607 | Terminated

• 1 other identifier: HHC-2015-0109
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Outcome Measures

Primary Outcomes (1)

• Understanding of Overactive Bladder questionnaire

  Change from baseline knowledge at follow up visit (on average 8 weeks)

Secondary Outcomes (2)

• Subject satisfaction questionnaire

  Baseline visit (time 0)

• Treatment success chart review

  8 months after baseline visit

Study Arms (2)

Standard Care Group

NO INTERVENTION

In this group, subjects will receive standard counseling regarding Overactive Bladder.

Care Plan Group

EXPERIMENTAL

In this group, subjects will receive counseling regarding Overactive Bladder using a printed "Overactive Bladder Plan of Care" information sheet.

Other: Overactive Bladder Care Plan counseling

Interventions

Overactive Bladder Care Plan counseling OTHER

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

Care Plan Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of overactive bladder
• able and willing to participate and consent
• age \>17 years, \<90 years
• female sex

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (3)

Hartford Hospital, Urogynecology Division

Glastonbury, Connecticut, United States

Location

Hartford Hospital, Urogynecology Division

Hartford, Connecticut, 06106, United States

Location

Hartford Hospital, Urogynecology Division

West Hartford, Connecticut, United States

Location

Related Publications (5)

• 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.

  PMID: 12559262 BACKGROUND

• 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.

  PMID: 18439051 BACKGROUND

• 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.

  PMID: 19954264 BACKGROUND

• 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.

  PMID: 15744452 BACKGROUND

• 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.

  PMID: 19531618 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

US (3)