Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Counseling to Optimize Medication Adherence in Expectant Mothers With Inflammatory Bowel Disease (COACH-IBD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03091309
• Other study ID #: COACH-IBD
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2020

Study information

• Verified date: September 2018
• Source: Mount Sinai Hospital, Canada
• Contact: Geoffrey C Nguyen, MD, PhD
• Phone: 416-586-4800
• Email: geoff.nguyen[@]utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Medication Adherence
• Ulcer
• Ulcerative Colitis

Intervention

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.
• 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.

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].
• 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].

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Crohn's and Colitis Canada

Country where clinical trial is conducted

Canada, 

References & Publications (21)

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Armstrong MJ, Mottershead TA, Ronksley PE, Sigal RJ, Campbell TS, Hemmelgarn BR. Motivational interviewing to improve weight loss in overweight and/or obese patients: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2011 Sep;12(9):709-23. doi: 10.1111/j.1467-789X.2011.00892.x. Epub 2011 Jun 21. Review. — View Citation

Barnes RD, Ivezaj V. A systematic review of motivational interviewing for weight loss among adults in primary care. Obes Rev. 2015 Apr;16(4):304-18. doi: 10.1111/obr.12264. Epub 2015 Mar 5. Review. — View Citation

Bernstein CN, Wajda A, Svenson LW, MacKenzie A, Koehoorn M, Jackson M, Fedorak R, Israel D, Blanchard JF. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol. 2006 Jul;101(7):1559-68. Erratum in: Am J Gastroenterol. 2006 Aug;101(8):1945. — View Citation

Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. Review. — View Citation

Cook PF, Emiliozzi S, El-Hajj D, McCabe MM. Telephone nurse counseling for medication adherence in ulcerative colitis: a preliminary study. Patient Educ Couns. 2010 Nov;81(2):182-6. doi: 10.1016/j.pec.2009.12.010. Epub 2010 Jan 15. — View Citation

Cornish J, Tan E, Teare J, Teoh TG, Rai R, Clark SK, Tekkis PP. A meta-analysis on the influence of inflammatory bowel disease on pregnancy. Gut. 2007 Jun;56(6):830-7. Epub 2006 Dec 21. Review. — View Citation

Dominitz JA, Young JC, Boyko EJ. Outcomes of infants born to mothers with inflammatory bowel disease: a population-based cohort study. Am J Gastroenterol. 2002 Mar;97(3):641-8. — View Citation

Easthall C, Song F, Bhattacharya D. A meta-analysis of cognitive-based behaviour change techniques as interventions to improve medication adherence. BMJ Open. 2013 Aug 9;3(8). pii: e002749. doi: 10.1136/bmjopen-2013-002749. Erratum in: BMJ Open. 2014;4(7). doi: 10.1136/bmjopen-2013-002749corr1. — View Citation

Ekong G, Kavookjian J. Motivational interviewing and outcomes in adults with type 2 diabetes: A systematic review. Patient Educ Couns. 2016 Jun;99(6):944-52. doi: 10.1016/j.pec.2015.11.022. Epub 2015 Dec 4. Review. — View Citation

Fidder HH, Singendonk MM, van der Have M, Oldenburg B, van Oijen MG. Low rates of adherence for tumor necrosis factor-a inhibitors in Crohn's disease and rheumatoid arthritis: results of a systematic review. World J Gastroenterol. 2013 Jul 21;19(27):4344-50. doi: 10.3748/wjg.v19.i27.4344. Review. — View Citation

Hedegaard U, Kjeldsen LJ, Pottegård A, Henriksen JE, Lambrechtsen J, Hangaard J, Hallas J. Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. Am J Med. 2015 Dec;128(12):1351-61. doi: 10.1016/j.amjmed.2015.08.011. Epub 2015 Aug 21. — View Citation

Hill S, Kavookjian J. Motivational interviewing as a behavioral intervention to increase HAART adherence in patients who are HIV-positive: a systematic review of the literature. AIDS Care. 2012;24(5):583-92. doi: 10.1080/09540121.2011.630354. Epub 2012 Jan 31. Review. — View Citation

Mocciaro F, Di Mitri R, Russo G, Leone S, Quercia V. Motivational interviewing in inflammatory bowel disease patients: a useful tool for outpatient counselling. Dig Liver Dis. 2014 Oct;46(10):893-7. doi: 10.1016/j.dld.2014.07.009. Epub 2014 Jul 30. — View Citation

Mountifield RE, Prosser R, Bampton P, Muller K, Andrews JM. Pregnancy and IBD treatment: this challenging interplay from a patients' perspective. J Crohns Colitis. 2010 Jun;4(2):176-82. doi: 10.1016/j.crohns.2009.10.001. Epub 2009 Dec 4. — View Citation

Nørgård B, Hundborg HH, Jacobsen BA, Nielsen GL, Fonager K. Disease activity in pregnant women with Crohn's disease and birth outcomes: a regional Danish cohort study. Am J Gastroenterol. 2007 Sep;102(9):1947-54. Epub 2007 Jun 15. — View Citation

Reddy D, Murphy SJ, Kane SV, Present DH, Kornbluth AA. Relapses of inflammatory bowel disease during pregnancy: in-hospital management and birth outcomes. Am J Gastroenterol. 2008 May;103(5):1203-9. doi: 10.1111/j.1572-0241.2007.01756.x. Epub 2008 Apr 16. — View Citation

Rocchi A, Benchimol EI, Bernstein CN, Bitton A, Feagan B, Panaccione R, Glasgow KW, Fernandes A, Ghosh S. Inflammatory bowel disease: a Canadian burden of illness review. Can J Gastroenterol. 2012 Nov;26(11):811-7. Review. — View Citation

Saghaei M. An overview of randomization and minimization programs for randomized clinical trials. J Med Signals Sens. 2011 Jan;1(1):55-61. — View Citation

Selinger CP, Eaden J, Selby W, Jones DB, Katelaris P, Chapman G, McDondald C, McLaughlin J, Leong RW, Lal S. Inflammatory bowel disease and pregnancy: lack of knowledge is associated with negative views. J Crohns Colitis. 2013 Jul;7(6):e206-13. doi: 10.1016/j.crohns.2012.09.010. Epub 2012 Oct 2. — View Citation

Trindade AJ, Ehrlich A, Kornbluth A, Ullman TA. Are your patients taking their medicine? Validation of a new adherence scale in patients with inflammatory bowel disease and comparison with physician perception of adherence. Inflamm Bowel Dis. 2011 Feb;17(2):599-604. doi: 10.1002/ibd.21310. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IBD-Specific Health Related Quality of Life (IBDQ)	Comparison of IBDQ as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	PRO-2 Scale for Crohn's Disease related disease activity	Comparison of scores on the PRO-2 scores as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	6-Point Mayo Score for Ulcerative Colitis related disease activity	Comparison of 6-Point Mayo Score as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	Patient Trust in Physician (TIPS)	Comparison of TIPS as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	Patient Satisfaction (CACHE)	Comparison of CACHE as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	IBD Specific Knowledge (CCKNOW)	Comparison of CCKNOW as a continuous variable using the the Mann-Whitney test between intervention and control groups.	Comparison of continuous variable at Baseline Gestational Week 34
Secondary	Fecal Calprotectin	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.	Comparison of dichotomous outcome at Baseline and Gestational Week 34
Secondary	Preterm 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.	Comparison of dichotomous outcome at Delivery
Secondary	Small for Gestational Age	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.	Comparison of dichotomous outcome at Delivery