Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

Not Applicable

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Medication Adherence
• 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

• Registration Number: NCT03091309
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-10-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Interactive educational video	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.
Intervention	Monthly follow-up questionnaires	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.
Intervention	Motivational interviewing	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.
Intervention	Telemedicine-based follow-up	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.
Intervention	Comprehensive questionnaires	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.
Intervention	Initial in-person counseling with an IBD nurse	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.
Control	Comprehensive questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Medication Adherence (MARS-5)	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

Name	Time	Method
IBD-Specific Health Related Quality of Life (IBDQ)	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.
Small for Gestational Age	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.
Patient Satisfaction (CACHE)	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)	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.
PRO-2 Scale for Crohn's Disease related disease activity	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.
Preterm Delivery	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.
Patient Trust in Physician (TIPS)	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.
Fecal Calprotectin	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.
6-Point Mayo Score for Ulcerative Colitis related disease activity	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.

Trial Locations

Locations (2)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada