Voiding Diary Video

NCT ID: NCT04233645

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2021-10-21

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

5-minute educational video

Intervention Type OTHER

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.

Usual Care

Intervention Type OTHER

The groups will be given a standard scripted verbal and identical written instructions as per usual care.

Usual Care Group

The group will be given a standard scripted verbal and identical written instructions as per usual care.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

The groups will be given a standard scripted verbal and identical written instructions as per usual care.

Interventions

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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.

Intervention Type OTHER

Usual Care

The groups will be given a standard scripted verbal and identical written instructions as per usual care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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2000026784

Identifier Type: -

Identifier Source: org_study_id

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