Overactive Bladder Education

NCT ID: NCT02505607

Last Updated: 2015-12-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Care Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Care Plan Group

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

Group Type: EXPERIMENTAL

Overactive Bladder Care Plan counseling

Intervention Type: OTHER

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

Interventions

Overactive Bladder Care Plan counseling

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Katie Propst

Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hartford Hospital, Urogynecology Division

Glastonbury, Connecticut, United States

Hartford Hospital, Urogynecology Division

Hartford, Connecticut, United States

Hartford Hospital, Urogynecology Division

West Hartford, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 12559262 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18439051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19954264 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15744452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19531618 (View on PubMed)

Other Identifiers

HHC-2015-0109

Identifier Type: -

Identifier Source: org_study_id