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OpenTrials
Completed

NCT Number: NCT02875977

Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?

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.

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Key information

Conditions

Patient Compliance Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Health Behavior Male Urogenital Diseases Patient Acceptance of Health Care Pelvic Floor Disorders Pregnancy Complications Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Video

Other

A 4-minute educational video describing PFPT

Educational handout

Other

A 2-page educational handout describing PFPT

Primary outcomes

  1. 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

Secondary outcomes

  1. Initiation of PFPT

    Time frame: 3 months

    The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling

  2. PFPT Discharge

    Time frame: 3 months

    The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling

  3. Days to Initiation of PFPT

    Time frame: 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

  4. Change in Urogenital Distress From Baseline to 3 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Elizabeth Mueller

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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