Voiding Diary Video
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-minute educational video
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Yale New Haven Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study Group
Usual Care Group
Arm Description
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.
The group will be given a standard scripted verbal and identical written instructions as per usual care.
Outcomes
Primary Outcome Measures
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.
Return Rate of Voiding Diaries
The rate of return of voiding diaries will be compared between the 2 groups.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04233645
Brief Title
Voiding Diary Video
Official Title
Effect of Educational Video on Patient Adherence and Completeness of Intake and Voiding Diaries
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
Active Comparator
Arm Description
The group will be given a standard scripted verbal and identical written instructions as per usual care.
Intervention Type
Other
Intervention Name(s)
5-minute educational video
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
The groups will be given a standard scripted verbal and identical written instructions as per usual care.
Primary Outcome Measure Information:
Title
Voiding Diary Grade
Description
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.
Time Frame
3 days
Title
Return Rate of Voiding Diaries
Description
The rate of return of voiding diaries will be compared between the 2 groups.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Patient Satisfaction: questionnaire
Description
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
Time Frame
3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
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