Recruiting

Counseling

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03091309

Conditions

Inflammatory Bowel Diseases

Medication Adherence

Crohn Disease

Ulcerative Colitis

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interactive educational video

Initial in-person counseling with an IBD nurse

Motivational interviewing

Telemedicine-based follow-up

Monthly follow-up questionnaires

Study Details

Brief 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

Conditions

Inflammatory Bowel Diseases

Medication Adherence

Crohn Disease

Ulcerative Colitis

Study ID

NCT03091309

Start date

Oct 1, 2017

Status verified date

Sep, 2018

Completion date

Oct 1, 2020

Anticipated

Primary completion date

Oct 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Have a confirmed diagnosis of IBD
  • Expected to be on an IBD-related medication throughout pregnancy
  • In First Trimester of Pregnancy
  • Willing to undergo pregnancy counseling with close monitoring
  • Able to provide informed consent

Exclusion Criteria:

  • Patients who are not residing in Ontario of Alberta
  • Unconfirmed diagnosis of IBD
  • In Second or Third Trimester of Pregnancy
  • Uncertainty regarding whether IBD medication will be prescribed throughout pregnancy
  • Unwilling to participate
  • Inability to provide informed consent

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

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.

active comparator: Control

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.

Interventions

Interactive educational video

A web-link to an educational video on IBD and pregnancy tailored to emphasize the importance of optimal disease control and medication adherence.

Initial in-person counseling with an IBD nurse

This session will emphasize key points from the educational video and the nurse will answer any additional questions the subject may have. The nurse will assess subjects' medication adherence and specifically query any concerns subjects may have regarding specific medications and discuss their intentions to be adherent throughout pregnancy.

Motivational interviewing

The nurse will be trained in a technique known as motivational interviewing (MI) specifically adapted for optimizing medication adherence during pregnancy.

Telemedicine-based follow-up

The IBD nurse will arrange follow-up visits with each subject on a monthly basis with additional ad-hoc sessions as needed. The encounter will focus on monitoring disease activity adherence and applying MI communication skills to reinforce and improve the latter.

Monthly follow-up questionnaires

Web-based short questionnaires, administered monthly, will be used to assess medication adherence \[self-reported using the 5 item Medication Adherence Report Scale (MARS-5)\] and IBD related disease activated \[self-reported using PRO-2 scale for Crohn's Disease related disease activity and 6-Point Mayo Score for Ulcerative Colitis related disease activity\].

Comprehensive questionnaires

Web-based detailed questionnaires, administered at enrolment and gestational week 34, will be used to assess medication adherence \[self-reported using the Medication Adherence Report Scale (MARS-5)\], patient trust in physician \[self-reported using the Trust in Physician Scale (TIPS)\], IBD related disease activated \[self-reported using the PRO-2 or 6-Point Mayo Score\], IBD-specific health related quality of life \[self-reported using the Inflammatory Bowel Disease Questionnaire (IBDQ)\], patient satisfaction \[self-reported using the Patient Satisfaction with Healthcare in Inflammatory Bowel Disease (CACHE) questionnaire\]and IBD specific knowledge \[self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire\].

Primary outcome measure

  • Medication Adherence (MARS-5) [ Time Frame: Comparison of dichotomous variable at Baseline and Gestational Week 34 ]

Central Contacts and Locations

Central contacts

Geoffrey C Nguyen, MD, PhD

416-586-4800geoff.nguyen@utoronto.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Geoffrey C Nguyen, MD, PhD

416-586-4800geoff.nguyen@utoronto.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Sep 19, 2018

Last verified

Sep, 2018

Keywords

  • Inflammatory Bowel Diseases
  • Medication Adherence
  • Crohn Disease
  • Ulcerative Colitis
  • Pregnancy
  • Counselling
  • Patient Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2018-09-19.