Trial of a Patient Education Tool For Leiomyoma

NCT ID: NCT03847077

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-21

Study Completion Date

2018-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Uterine Leiomyoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

iPad counseling

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Standard Counseling

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Linda Yang

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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207033

Identifier Type: -

Identifier Source: org_study_id

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