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Voiding Diary Video

Yale University logo

Yale University

Status

Completed

Conditions

Urinary Incontinence

Treatments

Other: Usual Care
Other: 5-minute educational video

Study type

Interventional

Funder types

Other

Identifiers

NCT04233645
2000026784

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

86 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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