Patient ComplianceNCT02875977
Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
A study testing Educational video and Educational handout in people with Patient Compliance and Pelvic Floor Disorders, run by Elizabeth Mueller at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Compliance, Pelvic Floor Disorders
- What is being tested?
- Educational video and Educational handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2016to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine \& Reconstructive Surgery practice
Who cannot join
- Patients ≤ 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
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.
Read the 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.
- Conditions
- Patient Compliance, Pelvic Floor Disorders
- Being tested
- Educational video, Educational handout
- Medical subject headings
- Patient Compliance, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
A 4-minute educational video describing PFPT
Educational handoutOther
A 2-page educational handout describing PFPT
| Study group | Role | What they receive |
|---|---|---|
| Experimental Counseling | Experimental | 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. Receives: Other: Educational video; Other: Educational handout |
| Standard Counseling | Active comparator | Patients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. Receives: Other: Educational handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
Initiation of PFPT
The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling
Measured: 3 months
PFPT Discharge
The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start3 Aug 2016
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patient ComplianceStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Mueller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Mueller, Loyola University
- Investigators
- Cynthia Brincat, MD, Principal investigator, Loyola UniversityElizabeth Mueller, MD, Study director, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875977
- Sponsor's protocol ID
- 208990
- Status last verified
- May 2019
- First submitted
- 18 Aug 2016
- Last updated
- 24 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers
Publications
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.
PubMed 25998493Fitzgerald 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.
PubMed 23234638Alewijnse 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.
PubMed 11345660Tibaek 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.
PubMed 23291858Shannon 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.
PubMed 29474290
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
- ClinicalTrials.gov ID
- NCT02875977
- Acronym / sponsor ID
- 208990
- Conditions
- Patient Compliance, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Elizabeth MuellerUniversity, hospital or other
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 27 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental Counseling | Experimental | Other: Educational video, Other: Educational handoutPatients 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. |
| Standard Counseling | Active comparator | Other: Educational handoutPatients randomized to this arm receive standard counseling on the importance of attending PFPT appointments. This includes the standard 2-page educational handout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have prescribed PFPT by a treating physician in the Female Pelvic Medicine \& Reconstructive Surgery practice
Key exclusion criteria (1 listed)
- Patients ≤ 18 years old
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 |
|---|---|---|
| Educational videoA 4-minute educational video describing PFPT | Other | Experimental Counseling |
| Educational handoutA 2-page educational handout describing PFPT | Other | Experimental Counseling, Standard Counseling |
Primary outcome
Number of Participants With Completed PT Visits
Time frame: 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
4 secondary outcomes
Initiation of PFPT
Time frame: 3 months
PFPT Discharge
Time frame: 3 months
Days to Initiation of PFPT
Time frame: 3 months
Change in Urogenital Distress From Baseline to 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25998493Dumoulin 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.
- Background: PubMed 23234638Fitzgerald 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.
- Background: PubMed 11345660Alewijnse 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.
- Background: PubMed 23291858Tibaek 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.
- Derived from this study: PubMed 29474290Shannon 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers
Related trials for Patient Compliance
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingPhase 4
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
Cataract, Surgery
Enrolling by invitationObservational study
Heart Rate Variability and Medication Adherence in Resistant Hypertension
Resistant Hypertension, Medication Adherence
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.
Cynthia Brincat, MD principal investigator
Loyola University
Elizabeth Mueller, MD study director
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video and Educational handout in people with Patient Compliance and Pelvic Floor Disorders, run by Elizabeth Mueller 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 1 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 24 May 2019. 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?
Yes. Results are posted in the registry (first posted 27 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Completed PT Visits (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875977, which also lists 5 linked publications.
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 24 May 2019; AzTrials last refreshed its copy on 3 Nov 2026.