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出境医 / 临床实验 / An Educational Video to Improve Patient Comprehension of Midurethral Sling

An Educational Video to Improve Patient Comprehension of Midurethral Sling

Study Description
Brief Summary:
The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Knowledge, Attitudes, Practice Other: Educational video Other: Educational leaflet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: An Educational Video to Improve Patient Comprehension of Midurethral Sling
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Intervention
The intervention group will be shown an educational video
 Other: Educational video
Short educational video describing the mid-urethral sling procedure
Active Comparator: Control
The control group will be given an educational leaflet
 Other: Educational leaflet
Standard educational leaflet describing the mid-urethral sling procedure
Outcome Measures
Primary Outcome Measures :
  1. Patient knowledge questionnaire (investigator-created) [ Time Frame: 6 weeks ]
    The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion Criteria:

  • < 18 years of age
  • Non-English speaking or requiring interpreter assistance
  • Presence of cognitive dysfunction
  • Women receiving a repeat midurethral sling (not primary)
  • Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
  • Pregnant women
Contacts and Locations

Contacts
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Contact: Huynh, Phuong Linh Huynh (714) 456-6155 plhuynh@uci.edu

Locations
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United States, California
University of California, Irvine Recruiting
Orange, California, United States, 92628
Contact: P Huynh    714-456-6155    plhuynh@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
Kaiser Permanente
Investigators
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Principal Investigator: Bhumy D Heliker, MD University of California, Irvine
Tracking Information
First Submitted Date  ICMJE January 15, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019) 		Patient knowledge questionnaire (investigator-created) [ Time Frame: 6 weeks ]
The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2019) 		Patient knowledge questionnaire [ Time Frame: 6 weeks ]
Change in knowledge as measured with a patient knowledge questionnaire
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Educational Video to Improve Patient Comprehension of Midurethral Sling
Official Title  ICMJE An Educational Video to Improve Patient Comprehension of Midurethral Sling
Brief Summary The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Urinary Incontinence
  • Knowledge, Attitudes, Practice
Intervention  ICMJE
  • Other: Educational video
    Short educational video describing the mid-urethral sling procedure
  • Other: Educational leaflet
    Standard educational leaflet describing the mid-urethral sling procedure
Study Arms  ICMJE
  • Experimental: Intervention
    The intervention group will be shown an educational video
    Intervention: Other: Educational video
  • Active Comparator: Control
    The control group will be given an educational leaflet
    Intervention: Other: Educational leaflet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 15, 2019) 		38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion Criteria:

  • < 18 years of age
  • Non-English speaking or requiring interpreter assistance
  • Presence of cognitive dysfunction
  • Women receiving a repeat midurethral sling (not primary)
  • Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
  • Pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Huynh, Phuong Linh Huynh (714) 456-6155 plhuynh@uci.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03808974
Other Study ID Numbers  ICMJE 2018-4707
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Kaiser Permanente
Investigators  ICMJE
Principal Investigator: Bhumy D Heliker, MD University of California, Irvine
PRS Account University of California, Irvine
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP