Trial of a Patient Education Tool For Leiomyoma

NCT03847077 | Completed

• 1 other identifier: 207033
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Uterine Leiomyoma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

iPad counseling

EXPERIMENTAL

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

Standard counseling

ACTIVE COMPARATOR

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

Interventions

iPad counseling 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.

iPad counseling

Standard Counseling 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.

Standard counseling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant
• English speaking
• Women aged 18-60 years
• presence of fibroids confirmed on imaging
• no confirmed or suspicion of malignancy

Sponsors & Collaborators

• Loyola University: lead

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 20, 2019
• Study Start: October 21, 2015
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02