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Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03091309
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Crohn's and Colitis Canada
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Medication Adherence Crohn Disease Ulcerative Colitis 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 Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Counseling to Optimize Medication Adherence in Expectant Mothers With Inflammatory Bowel Disease (COACH-IBD)
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: 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.

Behavioral: 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.

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

Behavioral: 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.

Other: 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].

Other: 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].

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.
Other: 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 Measures :
  1. Medication Adherence (MARS-5) [ Time Frame: Comparison of dichotomous variable at Baseline and Gestational Week 34 ]
    Comparison of medication adherence as a dichotomous outcome (adherent vs. non-adherent) using the chi-square statistic between intervention and control groups.


Secondary Outcome Measures :
  1. IBD-Specific Health Related Quality of Life (IBDQ) [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of IBDQ as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  2. PRO-2 Scale for Crohn's Disease related disease activity [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of scores on the PRO-2 scores as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  3. 6-Point Mayo Score for Ulcerative Colitis related disease activity [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of 6-Point Mayo Score as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  4. Patient Trust in Physician (TIPS) [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of TIPS as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  5. Patient Satisfaction (CACHE) [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of CACHE as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  6. IBD Specific Knowledge (CCKNOW) [ Time Frame: Comparison of continuous variable at Baseline Gestational Week 34 ]
    Comparison of CCKNOW as a continuous variable using the the Mann-Whitney test between intervention and control groups.

  7. Fecal Calprotectin [ Time Frame: Comparison of dichotomous outcome at Baseline and Gestational Week 34 ]
    Comparison of proportion of subjects with elevated fecal calprotectin scores, as an objective measure of inflammation and disease activity, between study groups using chi-square statistic.

  8. Preterm Delivery [ Time Frame: Comparison of dichotomous outcome at Delivery ]
    Gestational age recorded at delivery will be used to ascertain preterm delivery (<37 weeks) and compare rates of preterm delivery between study groups using chi-square statistic.

  9. Small for Gestational Age [ Time Frame: Comparison of dichotomous outcome at Delivery ]
    Birth weight recorded at delivery will be used to ascertain whether infants are small for gestational age and compare rates of small for gestational age infants at delivery between study groups using chi-square statistic.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091309


Contacts
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Contact: Geoffrey C Nguyen, MD, PhD 416-586-4800 ext 2819 geoff.nguyen@utoronto.ca

Locations
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Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Cynthia Seow, MBBS    403) 592-5089    cseow@ucalgary.ca   
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1X5
Contact: Geoffrey C Nguyen, MD, PhD    416-586-4800 ext 2819    geoff.nguyen@utoronto.ca   
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Crohn's and Colitis Canada
Investigators
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Principal Investigator: Geoffrey C Nguyen, MD, PhD Mount Sinai Hospital (Toronto, ON, Canada)

Publications:

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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03091309     History of Changes
Other Study ID Numbers: COACH-IBD
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Sinai Hospital, Canada:
Inflammatory Bowel Diseases
Medication Adherence
Crohn Disease
Ulcerative Colitis
Pregnancy
Counselling
Patient Education
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes