Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byGeoffrey C Nguyen, MD, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mount Sinai Hospital, Canada

No Placebo Group

Trial Summary

What is the purpose of this trial?

Inflammatory Bowel Disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that comprises two subtypes, Crohn's disease (CD) and Ulcerative Colitis (UC). Because the risk of IBD is greatest during the third decade of life, its impact for women is during the reproductive years. Women with inflammatory bowel disease are at a 2-fold higher risk of adverse outcomes during pregnancy as compared to the general population. Pregnancy is an especially vulnerable time for women with IBD, and out of misguided concerns that medications may confer unnecessary harms to their fetus, many women often stop taking life savings medications; without realizing that this sub-optimal adherence could actually lead to life threatening complications for them and their fetus. Counseling pregnant women with IBD is therefore an important step in improving medication adherence. The investigators hypothesize that counseling sessions with an IBD nurse that incorporates motivational interviewing and telemedicine-based follow-up sessions tailored to individual needs will improve medication adherence and pregnancy outcomes. The following specific aims are to be addressed by this multi-center randomized clinical trial comparing individual nurse-based counseling to standard of care: Specific Aim #1: To assess whether patient-centered counseling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication adherence during pregnancy and pregnancy outcomes Specific Aim #2: To validate the use of self-reported medication adherence during pregnancy in the IBD population

Research Team

Geoffrey C Nguyen, MD, PhD

Principal Investigator

Mount Sinai Hospital (Toronto, ON, Canada)

Eligibility Criteria

Inclusion Criteria

Have a confirmed diagnosis of IBD

Expected to be on an IBD-related medication throughout pregnancy

In First Trimester of Pregnancy

See 2 more

Treatment Details

Interventions

Comprehensive questionnaires (Other)
Initial in-person counseling with an IBD nurse (Behavioral Intervention)
Interactive educational video (Behavioral Intervention)
Monthly follow-up questionnaires (Behavioral Intervention)
Motivational interviewing (Behavioral Intervention)
Telemedicine-based follow-up (Behavioral Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment6 Interventions

Patients randomized to the intervention group will receive a multi-faceted intervention consisting of: (1) Interactive educational video; (2) Initial in-person counseling with an IBD nurse; (3) Motivational interviewing; (4) Telemedicine-based follow-up; (5) Monthly follow-up questionnaires; and (6) Comprehensive questionnaires.

Group II: ControlActive Control1 Intervention

Patients randomized to the control group will complete the comprehensive questionnaires and will continue to receive the standard of care consistent with their condition, at their respective institution.