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Intervention Video for Vaginal Bleeding (ACCCUSS Trial)

N/A
Waitlist Available
Led By Emily Godfrey, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

ACCCUSS Trial Summary

This study is a counseling intervention for new LNG-IUS users. The study explores the use of video technology to deliver anticipatory counseling on LNG-IUS side-effects, adjustment periods and bleeding changes to women newly using the LNG-IUS for contraceptive purposes. The primary aim is to understand if anticipatory counseling delivered via video can increase LNG-IUS satisfaction and continuation of the device in the first 6 months of use.

Eligible Conditions
  • Vaginal Bleeding
  • Menstrual Cramps

ACCCUSS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in LNG-IUS knowledge, satisfaction and continuation from baseline
Secondary outcome measures
LNG-IUS user self-reported LNG-IUS healthcare utilization during study period
LNG-IUS user self-reported satisfaction with video counseling
Number of subjects reporting LNG-IUS discontinuation during the study time frame (6 months) by reason for LNG-IUS removal
+1 more

ACCCUSS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Intervention VideoActive Control1 Intervention
Participants in this group will be assigned to watch a short educational video providing anticipatory counseling on their LNG-IUS' side effects and expected changes in bleeding. Intervention: Anticipatory Counseling
Group II: Control VideoPlacebo Group1 Intervention
Participants in this study arm will be assigned to watch a short educational video about new pap screening guidelines for women. Intervention: Cancer Screening Guidelines.

Find a Location

Who is running the clinical trial?

Cook County HealthOTHER_GOV
46 Previous Clinical Trials
16,017 Total Patients Enrolled
BayerIndustry Sponsor
2,235 Previous Clinical Trials
25,325,385 Total Patients Enrolled
University of California, Los AngelesOTHER
1,526 Previous Clinical Trials
10,275,726 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
Emily Godfrey 2016. "Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02752282.
~20 spots leftby Apr 2025
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