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Completed

NCT Number: NCT04233645

Voiding Diary Video

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-minute educational video

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

Other

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

Primary outcomes

  1. Voiding Diary Grade

    Time frame: 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.

  2. Return Rate of Voiding Diaries

    Time frame: 3 days

    The rate of return of voiding diaries will be compared between the 2 groups.

Secondary outcomes

  1. Patient Satisfaction: questionnaire

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2020
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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