Pelvic Organ ProlapseNCT04996563
Patient Educational Video for Pelvic Organ Prolapse
A study testing Video in people with Pelvic Organ Prolapse, run by Ohio State University at 1 site in United States.
Trial summary
This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management. 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?
- Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 12 Dec 2022
- 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
- Initial evaluation for symptomatic POP
- Age greater than or equal to 18 years old
- Reliable access to text or e-mail
Who cannot join
- Pregnant women
- Presence of cognitive disability
- Non-English speaking patient or requiring interpreter assistance
- Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Patient Educational Video to Enhance Patient Decision Satisfaction for the Treatment of Pelvic Organ Prolapse
This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.
Read the detailed description
This is a randomized controlled trial. Participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (POP) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). The counseling physician will be blinded. All participants will complete a pre-visit survey that includes the Prolapse and Incontinence Knowledge - POP (PIKQ-POP) and a demographics questionnaire. The PIKQ-POP has been validated to assess for patient knowledge of POP. Those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. At the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) to assess the primary outcome of change in patient decision satisfaction. The SDS is designed to assess satisfaction with a treatment decision. The SDS was modified into the SDS-PFD to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. To assess the secondary outcomes of change in decision conflict and POP knowledge, the post-visit survey will also include a validated Decision Conflict Scale (DCS) and the PIKQ-POP. The DCS was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. The physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. After undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the SDS-PFD and PIKQ-POP.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Video
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoOther
A brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options.
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | A brief educational video on POP will be sent electronically to participants randomized to the video group. Participants will view the video within one week prior to their consultation visit. Receives: Other: Video |
| No video | No intervention | Participants assigned to this group will not be sent the educational video to view. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in SDS-PFD score
The difference in the score of a validated decision satisfaction questionnaire, the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD), will be compared between the two arms. A difference of 0.4 will be considered clinically meaningful. The SDS-PFD was modified from the original SDS to be specific for women making decisions regarding surgical treatment for PFD. It has 6 questions with a 5-point response scale. The score is calculated by taking the mean of the 6 answers (1-5). Higher scores correspond with higher satisfaction.
Measured: Within 1 day of completion of the initial visit
Secondary outcomes (6)
Difference in DCS score
The difference in the score of the Decision Conflict Scale (DCS) will be compared between the two arms. The DCS has been validated to assess decision conflict related to treatment selection. It has 16 questions. Each question is answered on a 5-point Likert scale of 0 to 4. The scores are summed, divided by 16, and multiplied by 25. Final scores range from 0 to 100 with higher scores indicating higher decision conflict.
Measured: Within 1 day of completion of the initial visit
Difference in PIKQ-POP score
The difference in the Prolapse and Incontinence Knowledge - POP Questionnaire (PIKQ-POP) will be compared between the two arms. The PIKQ-POP has been validated to assess for patient knowledge of pelvic organ prolapse. It has 12 questions. Each correct question receives a score of 1. Each incorrect answer or answer of "I don't' know" receives a score of 0. The total score is the number of correct answers ranging from 0 to 12. Higher scores indicate higher POP knowledge.
Measured: Within 1 day of completion of the initial visit
Patient perception of their knowledge
The difference in the patient's perception of their knowledge will be compared between the two arms. Patients will be asked their perception of their level of knowledge of pelvic organ prolapse.
Measured: Within 1 day of completion of the initial visit
Physician's perception of patient's understanding of prolapse
The difference in the physician's perception of the patient's understanding of prolapse will be compared between the two arms. The physician will complete a counseling survey with a set of non-validated questions to assess their perception of if the patient viewed the video, the ease of counseling, and if the patient had a good understanding of their clinical issue.
Measured: Within 1 day of completion of the initial visit
Difference in SDS-PFD scores after management of prolapse
Patients will complete a final survey, the post-management survey. The difference in the patient's SDS-PFD scores will be compared between the two arms. The post-management survey will be administered in follow up to the patient after undergoing their chosen management option for the treatment of prolapse. Higher SDS-PDF scores correspond with higher satisfaction.
Measured: Within 2 weeks to 1 year after undergoing the chosen management option
Difference in PIKQ-POP scores after management of prolapse
Patients will complete a final survey, the post-management survey. The difference in the patient's PIKQ-POP scores will be compared between the two arms. The post-management survey will be administered in follow up to the patient after undergoing their chosen management option for the treatment of prolapse. Higher PIKQ-POP scores indicate higher POP knowledge.
Measured: Within 2 weeks to 1 year after undergoing the chosen management option
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start2 Aug 2021
- Primary completion17 May 2022
- Study completion12 Dec 2022
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.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned prospectively to one of two interventions to evaluate the effect of the educational video intervention on their knowledge of prolapse and satisfaction in their healthcare decision making for management of prolapse.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Hickman, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996563
- Sponsor's protocol ID
- 2021H0064
- Status last verified
- May 2023
- First submitted
- 13 Jul 2021
- Last updated
- 12 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Educational Video to Enhance Patient Decision Satisfaction for the Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT04996563
- Acronym / sponsor ID
- 2021H0064
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- 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.
This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.
Detailed description
This is a randomized controlled trial. Participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (POP) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). The counseling physician will be blinded. All participants will complete a pre-visit survey that includes the Prolapse and Incontinence Knowledge - POP (PIKQ-POP) and a demographics questionnaire. The PIKQ-POP has been validated to assess for patient knowledge of POP. Those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. At the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) to assess the primary outcome of change in patient decision satisfaction. The SDS is designed to assess satisfaction with a treatment decision. The SDS was modified into the SDS-PFD to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. To assess the secondary outcomes of change in decision conflict and POP knowledge, the post-visit survey will also include a validated Decision Conflict Scale (DCS) and the PIKQ-POP. The DCS was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. The physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. After undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the SDS-PFD and PIKQ-POP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Participants are randomly assigned prospectively to one of two interventions to evaluate the effect of the educational video intervention on their knowledge of prolapse and satisfaction in their healthcare decision making for management of prolapse.
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Other: VideoA brief educational video on POP will be sent electronically to participants randomized to the video group. Participants will view the video within one week prior to their consultation visit. |
| No video | No intervention | –Participants assigned to this group will not be sent the educational video to view. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Initial evaluation for symptomatic POP
- Age greater than or equal to 18 years old
- Reliable access to text or e-mail
Key exclusion criteria (4 listed)
- Pregnant women
- Presence of cognitive disability
- Non-English speaking patient or requiring interpreter assistance
- Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair
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 |
|---|---|---|
| VideoA brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options. | Other | Video |
Primary outcome
Difference in SDS-PFD score
Time frame: Within 1 day of completion of the initial visit
The difference in the score of a validated decision satisfaction questionnaire, the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD), will be compared between the two arms. A difference of 0.4 will be considered clinically meaningful. The SDS-PFD was modified from the original SDS to be specific for women making decisions regarding surgical treatment for PFD. It has 6 questions with a 5-point response scale. The score is calculated by taking the mean of the 6 answers (1-5). Higher scores correspond with higher satisfaction.
6 secondary outcomes
Difference in DCS score
Time frame: Within 1 day of completion of the initial visit
Difference in PIKQ-POP score
Time frame: Within 1 day of completion of the initial visit
Patient perception of their knowledge
Time frame: Within 1 day of completion of the initial visit
Physician's perception of patient's understanding of prolapse
Time frame: Within 1 day of completion of the initial visit
Difference in SDS-PFD scores after management of prolapse
Time frame: Within 2 weeks to 1 year after undergoing the chosen management option
Difference in PIKQ-POP scores after management of prolapse
Time frame: Within 2 weeks to 1 year after undergoing the chosen management option
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 12 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with Pelvic Organ Prolapse, run by Ohio State University 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 3 inclusion and 4 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 12 May 2023. 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?
Difference in SDS-PFD score (time frame: Within 1 day of completion of the initial visit). 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 12 May 2023.