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Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling (iPad)

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ClinicalTrials.gov Identifier: NCT01864408
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

The primary aim is to assess whether an interactive patient/provider counseling process using a web-based tool (iPadTM) will improve patient satisfaction regarding understanding of her bulge symptoms.

The secondary aims are to assess whether an interactive patient/provider counseling process using web-based tool (iPadTM) will:

  1. Decrease patient anxiety with counseling
  2. Improve patient satisfaction with counseling
  3. Improve provider knowledge, anxiety, and satisfaction with counseling
  4. Be easy to use in clinic
  5. Be actually used in clinic

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Other: "Usual practice" counseling Other: Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad). Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Interactive Patient and Provider Counseling on Pelvic Organ Prolapse: Do Patients Better Understand and Do Providers Better Counsel
Study Start Date : May 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1
Group 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam.
Other: "Usual practice" counseling
Other Name: Standard "usual practice" clinical counseling routinely performed after new patient history and physical exam.

Experimental: Group 2
Group 2: subjects will receive "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad) after new patient history and physical exam.
Other: Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).
After a new patient history and physical exam, with POP-Q exam, the subjects specific exam findings are entered into the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program. The program then constructs a cartoon of the subjects physical exam findings. This image is then used in counseling in addition to standard "usual practice" counseling.
Other Name: Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program.




Primary Outcome Measures :
  1. Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores. [ Time Frame: Day 1 ]
    Immediately before a history, physical, and counseling session subjects will fill out a Likert scale questionnaire (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Extremely Satisfied) to evaluate pre-visit satisfaction with understanding of bulge symptoms. After the history and physical exam subjects are randomized to group 1 or 2 for their counseling session. After the counseling session, they will fill out a similar Likert scale questionnaire to assess their satisfaction with understanding of their bulge symptoms. We will then compare the pre-visit and post-visit satisfaction with understanding of bulge symptoms for each group.


Secondary Outcome Measures :
  1. Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores. [ Time Frame: Day 1 ]
    Immediately before a history, physical, and counseling session subjects will fill out a Likert scale questionnaire (1=Not at all Anxious, 2=A little Anxious, 3=Moderately Anxious, 4=Very Anxious, 5=Extremely Anxious) to evaluate pre-visit anxiety related to bulge symptoms. After the history and physical exam subjects are randomized to group 1 or 2 for their counseling session. After the counseling session, they will fill out a similar Likert scale questionnaire to assess their anxiety regarding their bulge symptoms. We will then compare the pre-visit and post-visit anxiety related to bulge symptoms for each group.

  2. Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2). [ Time Frame: Day 1 ]
    At the end of the visit, Subjects will fill out a Likert scale questionnaire to evaluate overall satisfaction (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Extremely Satisfied) with counseling method received.

  3. Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse. [ Time Frame: Baseline and at 9 months ]
    All providers will fill out a Likert scale questionnaire to evaluate pre-study satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse. They will again complete the a similar questionnaire at the end of the study.

  4. Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice? [ Time Frame: At 9 months ]
    All providers will fill out a Likert scale questionnaire regarding iPad ease of use. They will also be asked if they planned to implement this tool into their practice (Y/N).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients

  • English speaking
  • Women over the age of 18
  • With complaints of symptomatic bulging from the vagina
  • Presenting as a new patient to University of North Carolina, Chapel Hill (UNC) Urogynecology clinic

Providers

  • All providers at UNC Urogynecology clinic will be allowed to participate in counseling sessions

Exclusion Criteria:

  • Patients not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864408


Locations
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United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Erinn M Myers, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01864408     History of Changes
Other Study ID Numbers: 12-0332
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: May 2013
Keywords provided by University of North Carolina, Chapel Hill:
Patient counseling
Patient satisfaction
Pelvic organ prolapse
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical