An interventional study of Educational video and Educational handout in Patient Compliance and Pelvic Floor Disorders, sponsored by Elizabeth Mueller. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Elizabeth Mueller · Not applicable, Interventional, and Health services research
Among 240 studies in Patient Compliance with a site in United States — 9 open to participants now, 19 under way, 1 of them phase 3. Patient Compliance · United States.
Among the 240 studies in Patient Compliance with a site in United States, this one is the 70th largest by enrollment of the 201 interventional ones that give a count, is one of 7 that started in 2016, is one of 160 with no phase, and was the 154th registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →9 of the 240 studies in Patient Compliance with a site in United States are open now. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 18+ · Healthy volunteers
VA Office of Research and Development · Sites in United States
Ages 18–90
HiDO Technologies · Sites in United States
Ages 65+
University of California, San Francisco · Sites in United States
Ages 60+
University of Georgia · Sites in United States
Ages 18–26 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
240 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 14 · Phase 3 12 · Phase 4 10
First in 1993; this study’s year is marked. 7 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 200 is above the median of 116 across 527 interventional studies indexed under Patient Compliance.
Median enrollment 119 across the 201 interventional studies, 92 across the 37 observational. Of the 203 that completed or were terminated, 64 (32%) have results posted.
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23 of 240 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Elizabeth Mueller as lead sponsor.
Elizabeth Mueller has 1 study filed under Patient Compliance — fewer than ten, so there is no comparison to draw.
6 of the studies in Patient Compliance with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07520786University of GeorgiaChanges in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women | 2026-11 |
| NCT04238949Children's Hospital of PhiladelphiaCommunity Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes | 2027-01 |
| NCT05448560Georgetown UniversityA Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship | 2027-02-28 |
| NCT05157113University of California, San FranciscoEvaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population | 2027-06-01 |
| NCT06591182BayCare Health SystemEffects of Social Determinants of Health on IV Iron Treatments | 2027-07 |
Add all 6 to your calendar (.ics) → With an account.
Among the 240 studies in Patient Compliance with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The investigators intend to measure compliance with attending pelvic floor physical therapy (PFPT) in a Urogynecology population by randomizing patients to either viewing a four minute educational video or reading a handout explaining the therapy.
Patients who have been interviewed, examined, and a plan has been made by the treating physicians in the Female Pelvic Medicine \& Reconstructive Surgery practice will be invited to participate at the end of the visit if the patient and physician mutually agree that PFPT is the treatment modality to pursue.
If she agrees to participate, she will be consented and randomized. If she is randomized to standard counseling, she will be given the standard handout to read. If she is randomized to the intervention, she will receive the standard handout and view the 4-minute educational video on an iPad.
At the conclusion of the counseling, patients will be asked if they have any additional questions, and these will be recorded and answered. The patient will also fill out a visual analog scale about how informed she feels regarding PFPT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients randomized to this arm receive experimental counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout and a 4-minute educational video.
Other: Educational video · Other: Educational handout
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
Other: Educational handout
A 4-minute educational video describing PFPT
A 2-page educational handout describing PFPT
Number of Participants With Completed PT Visits
The number of patients who completed at least half of their recommended PFPT visits is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
Initiation of PFPT
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
PFPT Discharge
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
Days to Initiation of PFPT
The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling
Time frame: 3 months
Change in Urogenital Distress From Baseline to 3 Months
Patients complete the Urinary Distress Inventory 6 (UDI-6) prior to beginning PFPT therapy and following PFPT therapy. The change in UDI-6 from baseline to 3 months following therapy is compared between those assigned to enhanced counseling versus standard counseling. The UDI-6 is an assessment of urogenital distress with a score range from 0 to 100, where higher scores indicate greater disability.
Time frame: 3 months
Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice.
| Milestone | Experimental Counseling | Standard Counseling |
|---|---|---|
| Started | 100 | 100 |
| Completed | 58 | 71 |
| Not completed | 42 | 29 |
| Withdrew: Lost to follow-up | 42 | 29 |
The number of patients who completed at least half of their recommended PFPT visits is compared between those assigned to enhanced counseling versus standard counseling
| Participants | Experimental Counseling | Standard Counseling |
|---|---|---|
| Completed half of the recommended visits | 47 | 50 |
| Did not complete half of the recommended visits | 11 | 21 |
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
| Participants | Experimental Counseling | Standard Counseling |
|---|---|---|
| Initiated PFPT | 58 | 71 |
| Did not initiate PFPT | 42 | 29 |
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
| Participants | Experimental Counseling | Standard Counseling |
|---|---|---|
| Discharged from PFPT | 27 | 33 |
| Not discharged from PFPT | 29 | 37 |
| PFPT discharge status unknown | 2 | 1 |
The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling
| Days | Experimental Counseling | Standard Counseling |
|---|---|---|
| Days to Initiation of PFPT | 15 (7 to 23) | 19 (11 to 31) |
Patients complete the Urinary Distress Inventory 6 (UDI-6) prior to beginning PFPT therapy and following PFPT therapy. The change in UDI-6 from baseline to 3 months following therapy is compared between those assigned to enhanced counseling versus standard counseling. The UDI-6 is an assessment of urogenital distress with a score range from 0 to 100, where higher scores indicate greater disability.
| units on a scale | Experimental Counseling | Standard Counseling |
|---|---|---|
| Change in Urogenital Distress From Baseline to 3 Months | -12.04 ± 21.29 | -16.49 ± 25.46 |
Collected over Adverse event data were collected for 11 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Counseling | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Standard Counseling | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Age, Continuous(years) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Mean | 57.32 ± 16.12 | 56.77 ± 17.00 | 57.05 ± 16.52 |
| Sex: Female, Male(Participants) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Hispanic or Latino | 24 | 24 | 48 |
| Not Hispanic or Latino | 76 | 75 | 151 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 13 | 28 |
| White | 81 | 78 | 159 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 6 | 8 |
| Region of Enrollment(participants) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| United States | 100 | 100 | 200 |
| Body Mass Index(kg/m^2) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Mean | 32.48 ± 8.24 | 29.94 ± 6.74 | 31.21 ± 7.62 |
| Primary Language(Participants) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| English | 95 | 94 | 189 |
| Spanish | 5 | 6 | 11 |
| Vaginal Parity(Pregnancies to a viable gestational age) | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Median | 2 (1 to 3) | 2 (1 to 3) | 2 (1 to 3) |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share individual participant data with other researchers
Ran from Aug 2016 to primary completion in Nov 2017, 15 months.
Results were first posted in Sep 2018, 10 months after primary completion.
Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 15 months is below that.
Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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