Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Sponsor
Elizabeth Mueller (Other)
Overall Status
Completed
CT.gov ID
NCT02875977
Collaborator
(none)
200
1
2
15.4
13
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized to standard counseling for pelvic floor physical therapy (PFPT) or to an experimental counseling group that comprises both standard counseling and a 4-minute PFPT educational video using a 1:1 allocationParticipants are randomized to standard counseling for pelvic floor physical therapy (PFPT) or to an experimental counseling group that comprises both standard counseling and a 4-minute PFPT educational video using a 1:1 allocation
Masking:
None (Open Label)
Masking Description:
No masking is used in this study
Primary Purpose:
Health Services Research
Official Title:
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Actual Study Start Date
:
Aug 3, 2016
Actual Primary Completion Date
:
Nov 15, 2017
Actual Study Completion Date
:
Nov 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Counseling 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
A 4-minute educational video describing PFPT
Other: Educational handout
A 2-page educational handout describing PFPT
|
| Active Comparator: Standard Counseling 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 2-page educational handout describing PFPT
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Completed PT Visits [3 months]
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
Secondary Outcome Measures
- Initiation of PFPT [3 months]
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
- PFPT Discharge [3 months]
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
- Days to Initiation of PFPT [3 months]
The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling
- Change in Urogenital Distress From Baseline to 3 Months [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine & Reconstructive Surgery practice
Exclusion Criteria:
- Patients ≤ 18 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
Sponsors and Collaborators
- Elizabeth Mueller
Investigators
- Principal Investigator: Cynthia Brincat, MD, Loyola University
- Study Director: Elizabeth Mueller, MD, Loyola University
Study Documents (Full-Text)
More Information
Publications
- Alewijnse D, Mesters I, Metsemakers J, Adriaans J, van den Borne B. Predictors of intention to adhere to physiotherapy among women with urinary incontinence. Health Educ Res. 2001 Apr;16(2):173-86.
- Dumoulin C, Alewijnse D, Bo K, Hagen S, Stark D, Van Kampen M, Herbert J, Hay-Smith J, Frawley H, McClurg D, Dean S. Pelvic-Floor-Muscle Training Adherence: Tools, Measurements and Strategies-2011 ICS State-of-the-Science Seminar Research Paper II of IV. Neurourol Urodyn. 2015 Sep;34(7):615-21. doi: 10.1002/nau.22794. Epub 2015 May 21. Review.
- Fitzgerald MP, Anderson RU, Potts J, Payne CK, Peters KM, Clemens JQ, Kotarinos R, Fraser L, Cosby A, Fortman C, Neville C, Badillo S, Odabachian L, Sanfield A, O'Dougherty B, Halle-Podell R, Cen L, Chuai S, Landis JR, Mickelberg K, Barrell T, Kusek JW, Nyberg LM; Urological Pelvic Pain Collaborative Research Network. Randomized multicenter feasibility trial of myofascial physical therapy for the treatment of urological chronic pelvic pain syndromes. J Urol. 2013 Jan;189(1 Suppl):S75-85. doi: 10.1016/j.juro.2012.11.018.
- Tibaek S, Dehlendorff C. Do women with pelvic floor dysfunction referred by gynaecologists and urologists at hospitals complete a pelvic floor muscle training programme? A retrospective study, 1992-2008. Int Urogynecol J. 2013 Aug;24(8):1361-9. doi: 10.1007/s00192-012-2018-2. Epub 2013 Jan 5.
Responsible Party:
Elizabeth Mueller,
MD, Associate Professor,
Loyola University
ClinicalTrials.gov Identifier:
NCT02875977
Other Study ID Numbers:
- 208990
First Posted:
Aug 23, 2016
Last Update Posted:
May 24, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patients were recruited from August 2016 through March 2017 (7 months) from a tertiary care female pelvic medicine and reconstructive surgery practice. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | Patients randomized to this arm receive experimental counseling on the importance of attending pelvic floor physical therapy (PFPT) appointments. This includes the standard 2-page educational handout and a 4-minute educational video. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Period Title: Overall Study | ||
| STARTED | 100 | 100 |
| COMPLETED | 58 | 71 |
| NOT COMPLETED | 42 | 29 |
Baseline Characteristics
| Arm/Group Title | Experimental Counseling | Standard Counseling | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. | Total of all reporting groups |
| Overall Participants | 100 | 100 | 200 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57.32
(16.12)
|
56.77
(17.00)
|
57.05
(16.52)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
100
100%
|
100
100%
|
200
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
24
24%
|
24
24%
|
48
24%
|
| Not Hispanic or Latino |
76
76%
|
75
75%
|
151
75.5%
|
| Unknown or Not Reported |
0
0%
|
1
1%
|
1
0.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
1%
|
3
3%
|
4
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
15
15%
|
13
13%
|
28
14%
|
| White |
81
81%
|
78
78%
|
159
79.5%
|
| More than one race |
1
1%
|
0
0%
|
1
0.5%
|
| Unknown or Not Reported |
2
2%
|
6
6%
|
8
4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
100
100%
|
100
100%
|
200
100%
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
32.48
(8.24)
|
29.94
(6.74)
|
31.21
(7.62)
|
| Primary Language (Count of Participants) | |||
| English |
95
95%
|
94
94%
|
189
94.5%
|
| Spanish |
5
5%
|
6
6%
|
11
5.5%
|
| Vaginal Parity (Pregnancies to a viable gestational age) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [Pregnancies to a viable gestational age] |
2
|
2
|
2
|
| Urogynecologic diagnosis (Count of Participants) | |||
| Stress Urinary Incontinence (SUI) |
9
9%
|
25
25%
|
34
17%
|
| Urgency Urinary Incontinence (UUI) |
25
25%
|
24
24%
|
49
24.5%
|
| Mixed Urinary Incontinence (MUI) |
34
34%
|
21
21%
|
55
27.5%
|
| Urgency-frequency syndrome |
27
27%
|
20
20%
|
47
23.5%
|
| Weak Pelvic Floor |
8
8%
|
14
14%
|
22
11%
|
| Defecatory dysfunction |
6
6%
|
6
6%
|
12
6%
|
| Pelvic Organ Prolapse (POP) |
10
10%
|
12
12%
|
22
11%
|
| Myofascial Pain |
40
40%
|
36
36%
|
76
38%
|
| Other Urogynecologic Diagnosis |
2
2%
|
2
2%
|
4
2%
|
Outcome Measures
| Title | Number of Participants With Completed PT Visits |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Measure Participants | 58 | 71 |
| Completed half of the recommended visits |
47
47%
|
50
50%
|
| Did not complete half of the recommended visits |
11
11%
|
21
21%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Counseling, Standard Counseling |
|---|---|---|
| Comments | The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.17 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.794 | |
| Confidence Interval |
(2-Sided) 95% 0.782 to 4.119 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Initiation of PFPT |
|---|---|
| Description | The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis comprises all participants who were randomized |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Measure Participants | 100 | 100 |
| Initiated PFPT |
58
58%
|
71
71%
|
| Did not initiate PFPT |
42
42%
|
29
29%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Counseling, Standard Counseling |
|---|---|---|
| Comments | The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.564 | |
| Confidence Interval |
(2-Sided) 95% 0.314 to 1.014 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | PFPT Discharge |
|---|---|
| Description | The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling |
| Time Frame | 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Measure Participants | 58 | 71 |
| Discharged from PFPT |
27
27%
|
33
33%
|
| Not discharged from PFPT |
29
29%
|
37
37%
|
| PFPT discharge status unknown |
2
2%
|
1
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Counseling, Standard Counseling |
|---|---|---|
| Comments | The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.90 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.044 | |
| Confidence Interval |
(2-Sided) 95% 0.517 to 2.110 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Days to Initiation of PFPT |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis comprises only the participants who were randomized and initiated PFPT |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Measure Participants | 58 | 71 |
| Median (Inter-Quartile Range) [Days] |
15
|
19
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Counseling, Standard Counseling |
|---|---|---|
| Comments | Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.16 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Z-Score |
| Estimated Value | -1.4262 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Urogenital Distress From Baseline to 3 Months |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis comprises only the participants who were randomized and had pre-PFPT and post-PFPT UDI-6 scores available |
| Arm/Group Title | Experimental Counseling | Standard Counseling |
|---|---|---|
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
| Measure Participants | 27 | 24 |
| Mean (Standard Deviation) [units on a scale] |
-12.04
(21.29)
|
-16.49
(25.46)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Experimental Counseling, Standard Counseling |
|---|---|---|
| Comments | The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.50 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.456 | |
| Confidence Interval |
(2-Sided) 95% -17.6149 to 8.7028 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 6.5481 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse event data were collected for 11 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Experimental Counseling | Standard Counseling | ||
| Arm/Group Description | 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. | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. | ||
All Cause Mortality |
||||
| Experimental Counseling | Standard Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/100 (0%) | ||
Serious Adverse Events |
||||
| Experimental Counseling | Standard Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/100 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Experimental Counseling | Standard Counseling | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | 0/100 (0%) | ||
Limitations/Caveats
There are no limitations or caveats to report
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Cynthia Brincat, M.D., Ph.D. |
|---|---|
| Organization | Loyola University Medical Center |
| Phone | 708-216-2180 |
| cbrincat@lumc.edu |
Responsible Party:
Elizabeth Mueller,
MD, Associate Professor,
Loyola University
ClinicalTrials.gov Identifier:
NCT02875977
Other Study ID Numbers:
- 208990
First Posted:
Aug 23, 2016
Last Update Posted:
May 24, 2019
Last Verified:
May 1, 2019