Voiding Diary Video

Effect of Educational Video on Patient Adherence and Completeness of Intake and Voiding Diaries

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: 5-minute educational video; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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.	Other: 5-minute educational video; The 5-minute educational video 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.; Other: Usual Care; The groups will be given a standard scripted verbal and identical written instructions as per usual care.
Active Comparator: Usual Care Group; The group will be given a standard scripted verbal and identical written instructions as per usual care.	Other: Usual Care; The groups will be given a standard scripted verbal and identical written instructions as per usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding Diary Grade	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.	3 days
Return Rate of Voiding Diaries	The rate of return of voiding diaries will be compared between the 2 groups.	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction: questionnaire	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: I was satisfied with the instructions given to me about how to complete a bladder diary (likert).; I understood the instructions about how to complete a bladder diary Yes/No; I referred back to my written instructions after I left the office Yes/No.; I referred to my video instructions after I left the office yes/ no	3 days

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence
• Other Study ID Numbers: 2000026784

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No