An interventional study of iPad counseling and Standard Counseling in Uterine Leiomyoma, sponsored by Loyola University. Completed. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-20.
Sponsored by Loyola University · Not applicable, Interventional, and Treatment
The goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.
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.
344 studies on the registry are indexed under Myofibroma; 41 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 244 interventional studies indexed under Myofibroma.
Browse Myofibroma studies →Loyola University is the lead sponsor of 134 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-
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 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 multimedia counseling using the drawMD OB/GYN iPad application.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
No study locations are listed for this record.
Ran from Oct 2015 to primary completion in Oct 2018, 36 months.
Of 39 non-industry interventional studies with no phase under Myofibroma, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 62. This study's 36 months is above that.
Counting every sponsor, half of 43 studies reached it within 25 months; a quarter within 12 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.