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Trial of a Patient Education Tool For Leiomyoma (PETAL)

Primary Purpose

Uterine Leiomyoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iPad counseling
Standard Counseling
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Leiomyoma

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Non-pregnant
  • English speaking
  • Women aged 18-60 years
  • presence of fibroids confirmed on imaging
  • no confirmed or suspicion of malignancy

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    iPad counseling

    Standard counseling

    Arm Description

    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive multimedia counseling using the drawMD OB/GYN iPad application

    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive standard counseling.

    Outcomes

    Primary Outcome Measures

    Change in patient knowledge scores
    Patients were asked baseline knowledge questions about fibroids prior to receiving physician counseling. Patients were randomized to iPad counseling or standard counseling groups. After the counseling session, patients answered similar knowledge questions about fibroids. The pre-counseling and post-counseling scores will be compared for each group. Generalized estimating equations were used to test whether any change in knowledge from pre-counseling to post-counseling was dependent on the participant's intervention assignment.
    Patient satisfaction post-counseling
    Patients completed a Likert scale questionnaire (1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Extremely Satisfied) to evaluate satisfaction with assigned counseling method.
    Patient anxiety pre-couseling
    Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids prior to receiving physician counseling.
    Patient anxiety post-couseling
    Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids after receiving physician counseling.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2019
    Last Updated
    February 18, 2019
    Sponsor
    Loyola University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03847077
    Brief Title
    Trial of a Patient Education Tool For Leiomyoma
    Acronym
    PETAL
    Official Title
    Randomized Trial of a Patient Education Tool For Leiomyoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 21, 2015 (Actual)
    Primary Completion Date
    October 31, 2018 (Actual)
    Study Completion Date
    October 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Loyola University

    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 goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.
    Detailed Description
    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive either standard counseling or multimedia counseling using the drawMD OB/GYN iPad application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and then completed a post-counseling questionnaire.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Leiomyoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    iPad counseling
    Arm Type
    Experimental
    Arm Description
    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive multimedia counseling using the drawMD OB/GYN iPad application
    Arm Title
    Standard counseling
    Arm Type
    Active Comparator
    Arm Description
    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive standard counseling.
    Intervention Type
    Behavioral
    Intervention Name(s)
    iPad counseling
    Intervention Description
    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive multimedia counseling using the drawMD OB/GYN iPad application.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Counseling
    Intervention Description
    Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive standard counseling.
    Primary Outcome Measure Information:
    Title
    Change in patient knowledge scores
    Description
    Patients were asked baseline knowledge questions about fibroids prior to receiving physician counseling. Patients were randomized to iPad counseling or standard counseling groups. After the counseling session, patients answered similar knowledge questions about fibroids. The pre-counseling and post-counseling scores will be compared for each group. Generalized estimating equations were used to test whether any change in knowledge from pre-counseling to post-counseling was dependent on the participant's intervention assignment.
    Time Frame
    Day 1
    Title
    Patient satisfaction post-counseling
    Description
    Patients completed a Likert scale questionnaire (1 = Very Dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Extremely Satisfied) to evaluate satisfaction with assigned counseling method.
    Time Frame
    Day 1
    Title
    Patient anxiety pre-couseling
    Description
    Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids prior to receiving physician counseling.
    Time Frame
    Day 1
    Title
    Patient anxiety post-couseling
    Description
    Participants completed a Likert scale questionnaire (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very Much) about their anxiety related to fibroids after receiving physician counseling.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-pregnant English speaking Women aged 18-60 years presence of fibroids confirmed on imaging no confirmed or suspicion of malignancy Exclusion Criteria: -

    12. IPD Sharing Statement

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    Trial of a Patient Education Tool For Leiomyoma

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