Trial of a Patient Education Tool For Leiomyoma

Uterine Leiomyoma Clinical Trial

— PETAL  

Official title:

Randomized Trial of a Patient Education Tool For Leiomyoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847077
• Other study ID #: 207033
• Status: Completed
• Phase: N/A
• Start date: October 21, 2015
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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:

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Leiomyoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1