Counseling to Optimize Adherence in Expectant Mothers With Inflammatory Bowel Disease
NCT ID: NCT03091309
Last Updated: 2018-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2017-10-01
2020-10-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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 \[self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire\].
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.
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 \[self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire\].
Interventions
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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.
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.
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 \[self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire\].
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Crohn's and Colitis Canada
OTHER
Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Principal Investigators
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Geoffrey C Nguyen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Hospital (Toronto, ON, Canada)
Locations
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University of Calgary
Calgary, Alberta, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Norgard 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. doi: 10.1111/j.1572-0241.2007.01355.x. Epub 2007 Jun 15.
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.
Abhyankar A, Ham M, Moss AC. Meta-analysis: the impact of disease activity at conception on disease activity during pregnancy in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Sep;38(5):460-6. doi: 10.1111/apt.12417. Epub 2013 Jul 15.
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.
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.
Fidder HH, Singendonk MM, van der Have M, Oldenburg B, van Oijen MG. Low rates of adherence for tumor necrosis factor-alpha 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.
Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. doi: 10.1016/S0738-3991(03)00141-1.
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):e002749. doi: 10.1136/bmjopen-2013-002749.
Hedegaard U, Kjeldsen LJ, Pottegard 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.
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.
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.
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.
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.
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.
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.
Saghaei M. An overview of randomization and minimization programs for randomized clinical trials. J Med Signals Sens. 2011 Jan;1(1):55-61.
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.
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. doi: 10.1155/2012/984575.
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. doi: 10.1111/j.1572-0241.2006.00603.x.
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. doi: 10.1136/gut.2006.108324. Epub 2006 Dec 21.
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. doi: 10.1111/j.1572-0241.2002.05543.x.
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Other Identifiers
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COACH-IBD
Identifier Type: -
Identifier Source: org_study_id
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