Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction

NCT02752282 | Unknown

• 1 other identifier: 49648
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Vaginal Bleeding; Uterine Cramping

Keywords

Family Planning; LNG-IUS; Health Education

Outcome Measures

Primary Outcomes (1)

• Change in LNG-IUS knowledge, satisfaction and continuation from baseline

  Using standardize questionnaires we will assess any significant differences in LNG-IUS knowledge, satisfaction or continuation after 6 months between control arm and intervention arm subjects.

  6 months

Secondary Outcomes (4)

• Percent of subjects in Phase II who complete all 3 surveys on-time over 6 months compared by recruitment method and site

  6 months

• Number of subjects reporting LNG-IUS discontinuation during the study time frame (6 months) by reason for LNG-IUS removal

  6 months

• LNG-IUS user self-reported satisfaction with video counseling

  6 months

• LNG-IUS user self-reported LNG-IUS healthcare utilization during study period

  baseline, 3 months, 6 months

Study Arms (2)

Control Video

SHAM COMPARATOR

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.

Other: Cancer Screening Guidelines

Intervention Video

ACTIVE COMPARATOR

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

Other: Anticipatory Counseling

Interventions

Anticipatory Counseling OTHER

Anticipatory Counseling provides information on expected side-effects that may change or go away over time, or stay for the duration of the treatment. Anticipatory counseling can also help patients understand when their side-effects are normal and when to seek medical attention.

Intervention Video

Cancer Screening Guidelines OTHER

Anticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines

Control Video

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 and over who are deemed appropriate candidates be their healthcare providers and choose to use LNG-IUS, either Mirena or Skyla.
• Within five days of FIRST using either Mirena or Skyla
• Willing to answer online questions before and after watching the assigned video (intervention or control)
• Willing to complete short online questionnaire at three and six months
• Has working email and/or phone number
• Able to understand verbal and written English
• Appropriate LNG-IUS candidates whoa re being treated for other pre-existing medical disorders while using the LNG IUS may continue to take their medications as directed by their healthcare provider.

You may not qualify if:

• Women aged less than 18 years old
• Initiated LNG-IUS method more than five days from enrollment date.
• Within six weeks postpartum
• Breastfeeding
• Using LNG-IUS for treatment other than contraception
• Do not have access to the Web
• Have neither working email or phone number
• Does not understand written or verbal English
• Inappropriate candidates for LNG IUS as deemed by healthcare provider

Sponsors & Collaborators

• University of Washington: lead
• Bayer: collaborator
• Cook County Health: collaborator
• University of California, Los Angeles: collaborator

Study Sites (3)

University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

University of Washington Medical Centers

Seattle, Washington, 98112, United States

Location

MeSH Terms

Conditions

Uterine Hemorrhage; Health Education

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Emily Godfrey, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Family Medicine

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 26, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (3)