Pelvic Organ ProlapseiPadNCT01864408
Interactive Web-Based Tool for Pelvic Organ Prolapse: Impact on Patient Understanding and Provider Counseling
A study testing "Usual practice" counseling and Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad). in people with Pelvic Organ Prolapse, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- "Usual practice" counseling and Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Interactive Patient and Provider Counseling on Pelvic Organ Prolapse: Do Patients Better Understand and Do Providers Better Counsel
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:
- Decrease patient anxiety with counseling
- Improve patient satisfaction with counseling
- Improve provider knowledge, anxiety, and satisfaction with counseling
- Be easy to use in clinic
- Be actually used in clinic
Read the detailed description
This will be a randomized controlled trial comparing conventional counseling regarding pelvic organ prolapse versus an interactive patient/provider counseling process using a pelvic organ prolapse web-based tool (iPad).
All women agreeing to enroll will:
- Complete a pre-visit questionnaire querying
- Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
- Anxiety related to their presenting symptoms
- Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.
- Patients will then be randomized and will either receive:
- Group 1: "usual practice" counseling regarding pelvic organ prolapse
- Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)
- Complete a post-visit questionnaire before leaving the office querying:
- Post-visit satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
- Anxiety related to their presenting symptoms
- Satisfaction with counseling received regarding their presenting bulging symptoms.
Provider assessment:
The providers participating in this study will:
- Complete a pre-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
- Watch a 2 minute video tutorial educating them on the use of the web-based interactive tool
- Complete a post-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
Powering the Study:
Assuming a 30% difference in satisfaction with knowledge of presenting bulge symptoms/ "pelvic anatomy", this study will enroll 45 pts in each arm (total of 90 pts) to achieve a power of 80% and an alpha of 0.05.
Analytic Plan: Statistical analysis will be performed with SPSS v 19.0 (Chicago, IL) and will include, where appropriate, categorical data analysis (Pearson chi-square, Fisher's Exact),continuous data analysis (Student's t-test, Mann-Whitney-U), and Pearson correlation, and logistic regression analyses where appropriate.
DATA COLLECTION:
Data will be collected by the project personnel. Patient demographic and physical exam data will be collected by physician members of the project personnel team during the single patient-visit of this trial. The physician members of the project personnel team will perform either the "usual practice" or "usual practice" plus "interactive, web-based tool-facilitated" patient counseling. Patient and provider questionnaire data will also be collected by the project personnel team.
Number and duration of subject contact: All data will be collected over the course of a patient's single "New Patient" visit. There will be no patient follow-up after this single visit.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- "Usual practice" counseling, Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).
- Keywords
- Patient counseling, Patient satisfaction, Pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Usual practice" counselingOther
Also called Standard "usual practice" clinical counseling routinely performed after new patient history and physical exam.
Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).Other
Also called Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Group 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam. Receives: Other: "Usual practice" counseling |
| Group 2 | Experimental | 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. Receives: Other: Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores.
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.
Measured: Day 1
Secondary outcomes (4)
Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores.
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.
Measured: Day 1
Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2).
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.
Measured: Day 1
Change in provider satisfaction with knowledge and anxiety regarding counseling and satisfaction with the ability to counsel women regarding pelvic organ prolapse.
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.
Measured: Baseline and at 9 months
Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice?
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).
Measured: At 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erinn M Myers, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864408
- Sponsor's protocol ID
- 12-0332
- Acronym
- iPad
- Status last verified
- May 2013
- First submitted
- 13 May 2013
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Patient and Provider Counseling on Pelvic Organ Prolapse: Do Patients Better Understand and Do Providers Better Counsel
- ClinicalTrials.gov ID
- NCT01864408
- Acronym / sponsor ID
- iPad / 12-0332
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Patient counseling, Patient satisfaction, Pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Decrease patient anxiety with counseling
- Improve patient satisfaction with counseling
- Improve provider knowledge, anxiety, and satisfaction with counseling
- Be easy to use in clinic
- Be actually used in clinic
Detailed description
This will be a randomized controlled trial comparing conventional counseling regarding pelvic organ prolapse versus an interactive patient/provider counseling process using a pelvic organ prolapse web-based tool (iPad).
All women agreeing to enroll will:
- Complete a pre-visit questionnaire querying
- Baseline satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
- Anxiety related to their presenting symptoms
- Undergo a new patient history and physical exam, including a pelvic organ prolapse quantification (POPQ) exam as per practice standard.
- Patients will then be randomized and will either receive:
- Group 1: "usual practice" counseling regarding pelvic organ prolapse
- Group 2: "usual practice" counseling in addition to interactive patient/provider counseling using the pelvic organ prolapse web-based tool (iPad)
- Complete a post-visit questionnaire before leaving the office querying:
- Post-visit satisfaction with knowledge of their presenting bulge symptoms ("pelvic anatomy")
- Anxiety related to their presenting symptoms
- Satisfaction with counseling received regarding their presenting bulging symptoms.
Provider assessment:
The providers participating in this study will:
- Complete a pre-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
- Watch a 2 minute video tutorial educating them on the use of the web-based interactive tool
- Complete a post-trial questionnaire assessing satisfaction with knowledge and anxiety regarding counseling, and satisfaction with ability to counsel women regarding pelvic organ prolapse.
Powering the Study:
Assuming a 30% difference in satisfaction with knowledge of presenting bulge symptoms/ "pelvic anatomy", this study will enroll 45 pts in each arm (total of 90 pts) to achieve a power of 80% and an alpha of 0.05.
Analytic Plan: Statistical analysis will be performed with SPSS v 19.0 (Chicago, IL) and will include, where appropriate, categorical data analysis (Pearson chi-square, Fisher's Exact),continuous data analysis (Student's t-test, Mann-Whitney-U), and Pearson correlation, and logistic regression analyses where appropriate.
DATA COLLECTION:
Data will be collected by the project personnel. Patient demographic and physical exam data will be collected by physician members of the project personnel team during the single patient-visit of this trial. The physician members of the project personnel team will perform either the "usual practice" or "usual practice" plus "interactive, web-based tool-facilitated" patient counseling. Patient and provider questionnaire data will also be collected by the project personnel team.
Number and duration of subject contact: All data will be collected over the course of a patient's single "New Patient" visit. There will be no patient follow-up after this single visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: "Usual practice" counselingGroup 1: subjects will receive "usual practice" counseling regarding pelvic organ prolapse after new patient history and physical exam. |
| Group 2 | Experimental | Other: Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Patients not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Usual practice" counselingAlso: Standard "usual practice" clinical counseling routinely performed after new patient history and physical exam. | Other | Group 1 |
| Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad).Also: Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program.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 | Group 2 |
Primary outcome
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.
4 secondary outcomes
Change in patient reported anxiety with understanding of bulge symptoms based on Likert scale scores.
Time frame: Day 1
Assessment of patient satisfaction after standard counseling (group 1) vs standard counseling with a web-based tool (ipad)(group 2).
Time frame: Day 1
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
Provider assessment: was the web-based tool easy to use, would you implement this tool into your practice?
Time frame: At 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erinn M Myers, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Usual practice" counseling and Standard "usual practice" clinical counseling with the pelvic organ prolapse web-based tool (iPad). in people with Pelvic Organ Prolapse, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported satisfaction with understanding of bulge symptoms based on Likert scale scores. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 28 Oct 2026.