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Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date September 19, 2018
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Medication Adherence (MMAS-8) [ Time Frame: Compairson of dichotomous outcome at 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
  • Medication Adherence (MMAS-8) [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    comparison of MMAS as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • IBD-Specific Health Related Quality of Life (IBDQ) [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of IBDQ as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • Harvey Bradshaw Index (HBI) for Crohn's Disease related disease activity [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of HBI as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • 6-Point Mayo Score (Mayo-6) for Ulcerative Colitis related disease activity [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of Mayo-6 as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • Patient Trust in Physician (TIPS) [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of TIPS as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • Patient Satisfaction (CACHE) [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of CACHE as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • IBD Specific Knowledge (CCKNOW) [ Time Frame: Compairson of cotinous variable at Gestational Week 34 ]
    Comparison of CCKNOW as a continuous variable using the the Mann-Whitney test between intervention and control groups.
  • Fecal Calprotectin [ Time Frame: Compairson of dichotomous outcome at 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.
  • Preterm Delivery [ Time Frame: Compairson 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.
  • Small for Gestational Age [ Time Frame: Compairson 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease
Official Title  ICMJE Counseling to Optimize Medication Adherence in Expectant Mothers With Inflammatory Bowel Disease (COACH-IBD)
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

Detailed Description

IBD and Pregnancy: 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), Canada has among the highest reported incidence of CD and UC in the world, as high as 20.2 and 19.5 per 100,000, respectively. Because the risk of IBD is greatest during the third decade of life, its greatest impact for women in during the reproductive years. In comparison to the general population, women with IBD have a significantly higher risk of pregnancy related complications.

IBD Disease Activity and Outcomes: Active IBD symptoms during pregnancy significantly increase the risk of preterm birth. Furthermore, women with IBD who suffer a relapse during pregnancy, requiring hospitalization, are more likely than their asymptomatic counterparts to delivery preterm birth and low birth weight newborns. More than two-thirds of women who have active disease at the time of conception will have continued or worsened symptoms during pregnancy. In contrast, women who are asymptomatic at conception are half as likely to have active disease during pregnancy. This data underscores the importance of achieving disease remission prior to conception and aggressively treating relapses during pregnancy.

Medication Adherence During Pregnancy: Despite the safety of most IBD medications, most pregnant women with IBD exhibit low medication adherence rates. Medication non-compliance is often linked to concerns that IBD medication may confer unnecessary harm to the fetus. Most women have reported that they would rather endure symptoms of IBD rather than confer risk to the fetus, without realizing that active IBD itself is strongly associated with adverse pregnancy outcomes. Consequently, most of these women decrease the dosage or stop their medications without informing their treating physicians, thus comprising treatment.

Motivational Interviewing Adherence: Motivational Interviewing (MI) refers to a patient-centered process in which a health care provider employs specific communication skills and strategies that facilitate the patients confidence and decision making, while emphasising respect for autonomy. A key feature of MI is that the counselling process induces behavioural change by triggering and channelling a patient's internal motivations for change. Previous clinical trials have demonstrated the effectiveness of MI in improving medication adherence for various chronic condition, including diabetes, hypertension, obesity and HIV. In a small study of IBD subjects, MI was associated with positive patient perceptions of the physician-patient relationship. In another pilot study, nurse-administered MI in UC patients was associated with medication adherence as high as 90%.

Rationale: Pregnancy is an especially vulnerable time for women with IBD. During this critical window of time, even brief lapses in medication adherence can lead to sub optimal control of IBD disease activity that can lead to life-threatening complications to both mother and fetus. Adverse outcomes such as preterm delivery have long-term implications for the children of mother with IBD. Out of misguided concerns for their fetus, many women may stop lifesaving medications. Educating pregnant women with IBD is an important step in improving adherence rates, but tools such as motivational interviewing have proven to be much more powerful. As such the primary objective of this study is to assess, through a multi-center clinical trial, whether patient-centered counselling incorporating motivational interviewing and telemedicine-based follow-up by an IBD nurse leads to improved medication adherence during pregnancy and improved pregnancy outcomes. The investigators hypothesize that patient-centered counselling will result in higher medication adherence rates and improved pregnancy outcomes.

Design: The investigators will conduct a multi-center randomized controlled clinical trial that includes 3 University of Toronto affiliated hospitals (Mount Sinai Hospital, University Health Network, and Women's College Hospital) and the University of Calgary.

Study Population: The investigators will enroll 220 pregnant women who have or will be seen by: an obstetrician or maternal fetal specialist at Mount Sinai Hospital or the University of Calgary; or a gastroenterologist at Mount Sinai Hospital, University Health Network, Women's College, or the University of Calgary who meet the inclusion criteria.

Significance: This clinical intervention has the potential to directly impact inflammatory bowel disease patients by reducing complications of the disease during pregnancy. Motivational interviewing can potentially improve adherence and optimize the impact of IBD medical therapies. Most tertiary centers already have clinical IBD nurses. The structured training of an IBD nurse to counsel pregnant women through motivational interviewing is a reproducible intervention and can be used at tertiary centers throughout the country. Because poor disease control can lead to preterm delivery, which is associated with lifelong chronic illnesses, patient-centered counselling would not only ameliorate the IBD health of mothers, but also improve the lives of their children. Findings from this study would also allow physicians to lobby provincial health ministries to request funds for IBD nurse counsellors.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Inflammatory Bowel Diseases
  • Medication Adherence
  • Crohn Disease
  • Ulcerative Colitis
Intervention  ICMJE
  • 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].
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • 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.
    Intervention: Other: Comprehensive questionnaires
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2017)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
150
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Geoffrey C Nguyen, MD, PhD 416-586-4800 ext 2819 geoff.nguyen@utoronto.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03091309
Other Study ID Numbers  ICMJE COACH-IBD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mount Sinai Hospital, Canada
Study Sponsor  ICMJE Mount Sinai Hospital, Canada
Collaborators  ICMJE Crohn's and Colitis Canada
Investigators  ICMJE
Principal Investigator: Geoffrey C Nguyen, MD, PhD Mount Sinai Hospital (Toronto, ON, Canada)
PRS Account Mount Sinai Hospital, Canada
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP