Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Primary Purpose
Patient Compliance, Pelvic Floor Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational video
Educational handout
Sponsored by
About this trial
This is an interventional health services research trial for Patient Compliance
Eligibility Criteria
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
Sites / Locations
- Loyola University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Counseling
Standard Counseling
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Initiation of PFPT
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
PFPT Discharge
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02875977
Brief Title
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Official Title
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2016 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth Mueller
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Compliance, Pelvic Floor Disorders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 allocation
Masking
None (Open Label)
Masking Description
No masking is used in this study
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Counseling
Arm Type
Experimental
Arm 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.
Arm Title
Standard Counseling
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout.
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
A 4-minute educational video describing PFPT
Intervention Type
Other
Intervention Name(s)
Educational handout
Intervention Description
A 2-page educational handout describing PFPT
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Brincat, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Mueller, MD
Organizational Affiliation
Loyola University
Official's Role
Study Director
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers
Citations:
PubMed Identifier
25998493
Citation
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.
Results Reference
background
PubMed Identifier
23234638
Citation
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.
Results Reference
background
PubMed Identifier
11345660
Citation
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. doi: 10.1093/her/16.2.173.
Results Reference
background
PubMed Identifier
23291858
Citation
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.
Results Reference
background
PubMed Identifier
29474290
Citation
Shannon MB, Adams W, Fitzgerald CM, Mueller ER, Brubaker L, Brincat C. Does Patient Education Augment Pelvic Floor Physical Therapy Preparedness and Attendance? A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):155-160. doi: 10.1097/SPV.0000000000000516.
Results Reference
derived
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Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
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