Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

NCT03091309 | Unknown

• 1 other identifier: COACH-IBD
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Medication Adherence (MARS-5)

  Comparison of medication adherence as a dichotomous outcome (adherent vs. non-adherent) using the chi-square statistic between intervention and control groups.

  Comparison of dichotomous variable at Baseline and Gestational Week 34

Secondary Outcomes (9)

• IBD-Specific Health Related Quality of Life (IBDQ)

  Comparison of continuous variable at Baseline Gestational Week 34

• PRO-2 Scale for Crohn's Disease related disease activity

  Comparison of continuous variable at Baseline Gestational Week 34

• 6-Point Mayo Score for Ulcerative Colitis related disease activity

  Comparison of continuous variable at Baseline Gestational Week 34

• Patient Trust in Physician (TIPS)

  Comparison of continuous variable at Baseline Gestational Week 34

• Patient Satisfaction (CACHE)

  Comparison of continuous variable at Baseline Gestational Week 34

Study Arms (2)

Intervention

EXPERIMENTAL

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.

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

Control

ACTIVE COMPARATOR

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.

Other: Comprehensive questionnaires

Interventions

Interactive educational video OTHER

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

Intervention

Initial in-person counseling with an IBD nurse BEHAVIORAL

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.

Intervention

Motivational interviewing BEHAVIORAL

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

Intervention

Telemedicine-based follow-up BEHAVIORAL

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.

Intervention

Monthly follow-up questionnaires OTHER

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 \[self-reported using PRO-2 scale for Crohn's Disease related disease activity and 6-Point Mayo Score for Ulcerative Colitis related disease activity\].

Intervention

Comprehensive questionnaires OTHER

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 \[self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire\].

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Crohn's and Colitis Canada: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

NOT YET RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

Related Publications (22)

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  PMID: 40243391 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Medication Adherence; Crohn Disease; Colitis, Ulcerative

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Geoffrey C Nguyen, MD, PhD

  Mount Sinai Hospital (Toronto, ON, Canada)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey C Nguyen, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)