NCT04233645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1.8 years

First QC Date

January 14, 2020

Last Update Submit

June 8, 2022

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Patient Satisfaction: questionnaire

    3 days

Study Arms (2)

Study Group

EXPERIMENTAL

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 videoOther: Usual Care

Usual Care Group

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

5-minute educational videoOTHER

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.

Study Group
Usual CareOTHER

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

Study GroupUsual Care Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

January 7, 2020

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Locations

US(1)