PETAL: Trial of a Patient Education Tool For Leiomyoma

Sponsor

Loyola University (Other)

Overall Status

Completed

CT.gov ID

NCT03847077

Collaborator

(none)

Enrollment

Arms

36.3

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Leiomyoma	Behavioral: iPad counseling Behavioral: Standard Counseling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Trial of a Patient Education Tool For Leiomyoma

Actual Study Start Date :

Oct 21, 2015

Actual Primary Completion Date :

Oct 31, 2018

Actual Study Completion Date :

Oct 31, 2018

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Loyola University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Linda Yang, MD, Associate Professor, Loyola University

ClinicalTrials.gov Identifier:

NCT03847077

Other Study ID Numbers:

207033

First Posted:

Feb 20, 2019

Last Update Posted:

Feb 20, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Feb 20, 2019