Trial of a Patient Education Tool For Leiomyoma

Not Applicable

Completed

• Conditions: Uterine Leiomyoma
• Interventions: Behavioral: Standard Counseling; Behavioral: iPad counseling

• Registration Number: NCT03847077
• Lead Sponsor: Loyola University

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.

Study Timeline

• Study Start: 2015-10-21
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-18
• Last Update Submitted: 2019-02-18
• Study First Posted: 2019-02-20
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard counseling	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.
iPad counseling	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

Primary Outcome Measures

Name	Time	Method
Change in patient knowledge scores	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.
Patient satisfaction post-counseling	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.
Patient anxiety pre-couseling	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.
Patient anxiety post-couseling	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.