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Intervention for Crohn's Disease

N/A
Waitlist Available
Led By Geoffrey C Nguyen, MD, PhD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparison of continuous variable at baseline gestational week 34
Awards & highlights

Study Summary

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

Eligible Conditions
  • Crohn's Disease
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Medication Adherence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~comparison of continuous variable at baseline gestational week 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and comparison of continuous variable at baseline gestational week 34 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication Adherence (MARS-5)
Secondary outcome measures
6-Point Mayo Score for Ulcerative Colitis related disease activity
Fecal Calprotectin
IBD Specific Knowledge (CCKNOW)
+6 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Motivational interviewing
2011
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

Crohn's and Colitis CanadaOTHER
7 Previous Clinical Trials
1,112 Total Patients Enrolled
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,388 Total Patients Enrolled
Geoffrey C Nguyen, MD, PhDPrincipal InvestigatorMount Sinai Hospital (Toronto, ON, Canada)
1 Previous Clinical Trials
160 Total Patients Enrolled

Frequently Asked Questions

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Recent research and studies
~29 spots leftby Apr 2025