Trial of a Patient Education Tool For Leiomyoma (PETAL)

February 18, 2019 updated by: Linda Yang, Loyola University

Randomized Trial of a Patient Education Tool For Leiomyoma

The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iPad counseling
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
Behavioral: iPad counseling
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.
Active Comparator: Standard counseling
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.
Behavioral: Standard Counseling
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient knowledge scores
Time Frame: Day 1
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.
Day 1
Patient satisfaction post-counseling
Time Frame: Day 1
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.
Day 1
Patient anxiety pre-couseling
Time Frame: Day 1
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.
Day 1
Patient anxiety post-couseling
Time Frame: Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2015

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 207033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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