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The purpose of the TEAM study is to test the efficacy of a telehealth behavioral treatment protocol to improve medication adherence in children and adolescents (ages 11-18) with inflammatory bowel disease via a randomized controlled clinical trial. Participants are randomized to either a telehealth behavioral treatment protocol or an educational intervention. In order to examine clinical significance of the intervention, treatment outcomes will include disease severity, HRQOL, and health care utilization in addition to medication adherence.
This study is funded by the National Institutes of Health (NIH) / National Institute of Child Health and Human Development (NICHD): R01 HD067174-01
The LEAD study is a retrospective study examining the trajectories of medication nonadherence and their impact on disease severity and symptoms in pediatric patients (ages 2 - 21) with inflammatory bowel disease. We also are examining how medication nonadherence may impact inflammatory markers and endoscopic findings. The results of the study will ultimately be used to inform the timing of early interventions aimed at improving adherence and quality of care in this population.
Open Source Science: Transforming Chronic Illness Care
[Collaborative Chronic Care Network (C3N)]
The C3N is a multisite project conducted with PIs Michael Seid, PhD, and Peter Margolis, PhD. The major goal of this study is to design, prototype, optimize and evaluate a patient-provider collaborative care network for pediatric IBD. Ultimately we hope to improve clinical practice, patient self-management and disease outcomes.
This study is funded by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases: R01 DK085719.
Behavioral Treatment of Nonadherence in Pediatric Inflammatory Bowel Disease
[Promoting Adherence to Crohn’s and Colitis Treatment (PACCT)]
The PACCT study is a randomized clinical trial examining the efficacy, feasibility and acceptability of a family-based group behavioral treatment. The treatment is intended to improve medication adherence in a sample of adolescents (ages 11-17) with inflammatory bowel disease (IBD). The study is also assessing disease severity, health-related quality of life (HRQOL) and patient and family behavioral functioning.
This study was funded by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): K23 DK079037.
Promoting Treatment Adherence in Pediatric Inflammatory Bowel Disease
[Facilitating Adherence in Crohn’s and Colitis Treatment (FACCT)]
The FACCT study is a randomized controlled clinical trial examining the feasibility and efficacy of a “group plus individually tailored” treatment protocol, compared to group-only treatment, to improve medication adherence in children and adolescents (ages 11-18) with IBD. This study is also examining disease severity and HRQOL as secondary outcomes.
This study was funded by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases: R03 DK087822.
The I
MACC study is a randomized controlled clinical trial examining the efficacy of an individually-tailored, family-based behavioral intervention aimed at improving adherence to medication in children and adolescents (ages 11 - 18) with inflammatory bowel disease (IBD). The intervention is delivered either in person or via webcam. Health outcome, patient and family functioning, and quality of life are also being examined in this study.
This project was
sponsored by the Digestive Health Center, Cincinnati Children’s Hospital
Medical Center: P30 DK078392
The TASCC study is a longitudinal assessment study. In it, we examine treatment adherence, concomitant patient and family behavioral functioning and QOL in adolescents (ages 13-17) with IBD. The primary aims of this study are to identify behavioral factors related to nonadherence in this population, and to examine patterns of adherence and related factors over time. The study’s findings will inform continued intervention research.
This study was supported by Prometheus Laboratories and Procter & Gamble Pharmaceuticals.
The EGID adherence study is a cross-sectional examination of several factors related to living with chronic illness. We are studying dietary and medication adherence and patient / family behavioral functioning in children and adolescents (ages 2.5-18) with eosinophil-associated gastrointestinal disorders. The primary aim of this study is to document the adherence and behavioral challenges these families face to provide targets for future intervention research; ultimately, this research will help us improve adherence and QOL in this population.
Our lab is collaborating with colleagues at the Children’s Hospital of Philadelphia (PI: Mary Leonard, MD) on this project. Our primary aim is to determine if treatment with low-magnitude mechanical stimuli results in increased bone mineral density in children and adolescents with Crohn’s disease. We are collecting adherence data, and we are providing a tailored problem solving intervention to patients who fall below 80 percent of the prescribed treatments in a given month.
Funding for this study was provided by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases: R01 DK073946.
Our lab is collaborating on this project with colleagues at the Children’s Hospital of Philadelphia (Virginia Stallings, MD) and Avanti Polar Lipids Inc. (Walter Shaw, PhD). The goal of this study is to determine if Lym-X-Sorb, a novel lipid matrix, is an acceptable, effective supplement to correct the metabolic and physiological abnormalities associated with fat malabsorption, essential fatty acid deficiency and choline deficiency in patients with CF. We are collecting adherence data and provide a tailored problem solving and behavioral intervention to patients who fall below 80 percent of prescribed treatments in a given month.
Funding was provided by the National Institutes of Health (NIH) / National Institute of Diabetes and Digestive and Kidney Diseases: SBIR R44 DK060302.
The purpose of this study is to develop content for the Pediatric Eosinophilic Esophogitis Symptom Severity Questionnaire (PEESS) and the pediatric EE Health Related Quality of Life instrument (PEEHRQoL) by interview focus groups. The PEEHRQoL instrument will capture the effect of eosinophilic esophagitis on the health of patients as a multidimensional construct that affects quality of life domains. The PEESS will be reviewed and modified, if necessary, to appropriate age levels.
Funding was provided by the Children's Digestive Health and Nutrition Foundation.
The goal of this study is to establish the validity, reliability, and responsiveness of the Pediatric Eosinophilic Espophagitis Health-Related Quality of Life (PEEHRQOL) and revised Pediatric Eosinophilic Esophagitis Symptom Severity (PEESS) instruments.
Funding was provided by the Children's Digestive Health and Nutrition Foundation.
This protocol is open for the disclosure of information from three CCHMC studies to provide an independent assessment of the outcome variables important in EoE, and to support the FDA qualification process of the following clinical outcome assessments: (1) Pediatric EoE Symptom Severity Module (PEESSTM v.2.0); (2) PedsQLTM Pediatric EoE Health Related Quality of Life Module (PEEHRQOL v.1.0); and (3) other EoE Patient-Report Outcome Measures (PROs).
The objective of this study is to field test age-appropriate versions of the newly developed multidimensional PedsQL™ Gastrointestinal Symptoms Module for pediatric patient self-report for ages 5-18 and parent proxy-report for ages 2-18 across functional gastrointestinal disorders of childhood.
