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临床试验/NCT02505607
NCT02505607终止不适用

Overactive Bladder Education

Hartford Hospital3 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
3
主要终点
Understanding of Overactive Bladder questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Overactive Bladder Care Plan counseling (Other)

结局指标

主要结局

Understanding of Overactive Bladder questionnaire

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

次要结局

  • Treatment success chart review(8 months after baseline visit)
  • Subject satisfaction questionnaire(Baseline visit (time 0))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katie Propst

Fellow

Hartford Hospital

研究点 (3)

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