Voiding Diary Video

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: Other: 5-minute educational video; Other: Usual Care

• Registration Number: NCT04233645
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-18
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Need for intake and voiding diary completion
• Deemed to required return visit or follow up
• Able to read and write English

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Exclusion Criteria

• Dementia
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	5-minute educational video	The group will be given a standard scripted verbal and identical written instructions plus the study group will be shown a 5-minute educational video (available at https://youtu.be/rvYfDc-Yfus ) which depicts key components of entering data on the diary. Patients in this group will also have online access to the video when they are filling out their diaries.
Study Group	Usual Care	The group will be given a standard scripted verbal and identical written instructions plus the study group will be shown a 5-minute educational video (available at https://youtu.be/rvYfDc-Yfus ) which depicts key components of entering data on the diary. Patients in this group will also have online access to the video when they are filling out their diaries.
Usual Care Group	Usual Care	The group will be given a standard scripted verbal and identical written instructions as per usual care.

Primary Outcome Measures

Name	Time	Method
Voiding Diary Grade	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	3 days	The rate of return of voiding diaries will be compared between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction: questionnaire	3 days	A qualitative measure developed for the study will be used to assess the patient satisfaction. It consists of 4 questions, 1 Likert and 3 Yes/No questions. Each of these questions will be compared between the 2 groups. The questions are: 1. I was satisfied with the instructions given to me about how to complete a bladder diary (likert).; 2. I understood the instructions about how to complete a bladder diary Yes/No; 3. I referred back to my written instructions after I left the office Yes/No.; 4. I referred to my video instructions after I left the office yes/ no

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States