ImproveCareNow is transforming care, health and costs for all children and youth with IBD through continuous improvement, innovation and discovery. Below is a listing of our current research projects.

Click on a project name to view additional information.

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Purpose: This study uses data from the ImproveCareNow Registry to examine the duration and effectiveness of Adalimumab therapy in pediatric Crohn’s Disease within the ICN network.  This knowledge is an important step in learning how to optimize the use of Adalimumab.

Funding Source: AbbVie (2016)

Study Period : 2015-2017

Recruitment Status: Not recruiting participants

Contact: ImproveCareNow Research 

More Information:

ImproveCareNow registry used to evaluate use of concomitant immunomodulators with adalimumab therapy in Crohn's Disease

Evaluation of adalimumab effectiveness in anti-tumor necrosis factor-naïve pediatric patients with Crohn's disease in clinical practice

Purpose: By using data that exists in the ImproveCareNow Registry, this study aims to measure the duration and effect of adalimumab on clinical outcomes in pediatric ulcerative colitis patients in the clinical practice setting.  This study will add to the knowledge about the use of adalimumab as therapy in the management of pediatric ulcerative colitis.

Funding Source (Year Awarded): AbbVie (2016)

Study Period: 2016-2017

Recruitment Status:  Not recruiting participants

Contact: ImproveCareNow Research

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Purpose: The COMBINE trial will study if treatment with a single anti-TNF medication (infliximab and adalimumab) or dual therapy that includes methotrexate is more effective in children with moderate to severe Crohn’s disease. COMBINE is the first study to look at this question in children with Crohn’s disease. We expect that 425 kids from across the US will enter the study. The results of this study can be used to help doctors choose medications that help children the most.

Funding Source (Year Awarded): Patient Centered Outcomes Research Institute (2015)

Study Period: 2015-2020

Recruitment Status: Currently recruiting participants 

Contact: Michelle Robinson, Project Manager, UNC 

For more information

COMBINE Trial Website

Care Centers - Find a participating COMBINE center

LOOP blog posts

The COMBINE Study

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Purpose: The GROWING study, which stands for Predictors of continued statural GROWth IN older adolescents and younG adults with Crohn’s disease and ulcerative colitis, aims to determine the prevalence of continued growth and to quantify total height gain and height velocity in older adolescents and young adults with Crohn’s disease and ulcerative colitis after the chronological age of expected growth plate closure. We will determine predictors and associative factors of continued growth in these patients.

Funding Source (Year Awarded): Celgene (September 2016)

Study Period: February – December 2017

Recruitment Status: Not recruiting participants

Contact: Michelle Spotts

 

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Purpose: This study will randomize participants to either eight sessions of online mindfulness-based treatment ("standard") or a briefer, three-session online mindfulness-based treatment ("light") to compare the treatments' efficacy and acceptability across a wide range of conditions and special populations. 

Funding Source: PCORI (2016)

Study Period: May 2016-July 2019

Recruitment Status: Not yet recruiting participants 

Contact: Melissa Mock 

More information:

PCORI.org - Healthy Mind, Healthy You 

ImproveCareNow Network to Participate in $4 Million Research Study Comparing Stress Management Approaches

 

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Co- Investigators: David Suskind, MD, Shehzad Saeed, MD & Kimberly Braly, RD

Clinician Stakeholders: Jennifer Burgis, MD & Kaylie Nguyen, PNP

Parent Stakeholders: Sheri Pilley, Julie Stone, Gisele Woodward

Patient Stakeholders: Alex Jofriet & Catalina Berenblum

Project Staff: Michelle Jeffcott-Pera, MA

Purpose: PRODUCE study, which stands for Personalized Research on Diet in Ulcerative Colitis and Crohn’s Disease, is a first of its kind nutrition intervention study in IBD. With evidence showing dietary intervention has an impact on disease activity for patients with IBD, the PRODUCE study aims to determine the effectiveness of the Specific Carbohydrate Diet (SCD) in reducing symptoms and inflammatory burden in patients with IBD and compare this to a modified form of the SCD. Over the course of this project, a series of N-of-1 studies will be used to examine how the SCD affects individual patients. In addition, we will combine the results of approximately 100 individual N-of-1 studies to look at the effectiveness of the SCD in the pediatric IBD population.

Primary Outcomes: Patient reported outcomes of:

  • Daily stool frequency
  • Daily stool consistency
  • Weekly PROMIS Pain Interference
  • Weekly PROMIS GI symptom severity
  • Fecal calprotectin

Secondary Outcomes: 

  • Short Crohn’s Disease Activity Index (SCDAI)
  • Clinically-evaluated disease activity scores and laboratory markers contained in ICN registry:
    • PUCAI and SPCDAI
    • Growth
    • CRP, HCT, Albumin, ESR
  • Microbiome analyses

Funding Source: Patient Centered Outcomes Research Institute (PCORI; Awarded January 2017)

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