Effect of Educational Video on Patient Adherence and Completeness of Intake and Voiding Diaries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Voiding Diary Grade
研究概览
简要总结
The aim of this study is to evaluate patient adherence and completeness of intake and voiding diaries. The secondary goal is to compare the satisfaction and understanding of patients of the intake and voiding trial diaries directions.
详细描述
This is a randomized prospective study. All women who need to complete an intake and voiding diary at the Yale Urogynecology outpatient facilities will be invited to participate. After completion of the consent process, they will be randomized to one of two groups. Both groups will have their voiding diaries analyzed by three blinded experts and will be graded on completeness of the information filled out. The mean grade obtained from this process and the return rate of the voiding diaries will be the primary outcomes. The secondary outcomes will include a brief patient questionnaire on their satisfaction of the instructions with the voiding diary. The primary and secondary outcomes will be evaluated between the groups to determine the effectiveness of the video intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Need for intake and voiding diary completion
- •Deemed to required return visit or follow up
- •Able to read and write English
排除标准
- •Prisoners
- •Pregnant Patients
- •Medical and physical handicaps which may interfere with completion of intake and voiding diary
- •Medical and physical handicaps with viewing or understanding of the educational video
- •Illiterate patients
- •Patients who cannot speak and understand English
结局指标
主要结局
Voiding Diary Grade
时间窗: 3 days
Voiding diaries will be evaluated by 3 blinded experts for completeness. The average of these 3 grades will be used to evaluate the intervention compared to the usual care group. Data entries can either be a void, leak, or fluid intake. Each data entry will be identified as either a leak, void, or fluid intake and then given a score based on completeness. Then these scores will be averaged with all the same type of entries per day and totaled, for a maximum total per day of 9. The maximum score is 9. A higher score means that the diary is determined to be more complete. The lowest score is 0, meaning the voiding diary was not complete. Each of the three days will then be averaged giving a final quality score for the returned voiding diary.
Return Rate of Voiding Diaries
时间窗: 3 days
The rate of return of voiding diaries will be compared between the 2 groups.
次要结局
- Patient Satisfaction: questionnaire(3 days)