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CCFA Partners: An Internet-based Cohort Study. Robert S. Sandler, MD, MPH University of North Carolina Chapel Hill, NC. Outline. Introduction – name, vision, who we are How it works Enrollment/retention What we have learned so far Sharing the results Ancillary studies Validation study
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CCFA Partners: An Internet-based Cohort Study Robert S. Sandler, MD, MPH University of North Carolina Chapel Hill, NC
Outline • Introduction – name, vision, who we are • How it works • Enrollment/retention • What we have learned so far • Sharing the results • Ancillary studies • Validation study • Biospecimen feasibility • New directions • Summary
The name IBD patient community CCFA UNC research team
CCFA partners research team • Robert Sandler, MD, MPH, PI • Michael Kappelman, MD, MPH, co-PI • Millie Long, MD, MPH, co-PI • Kristen Anton, informatics director • Chris Martin, MPH, epidemiologist • Wenli Chen, programmer • Beth Jaeger, project manager • Lucy Goble, research assistant
Our vision • Use Internet-based recruitment and data collection to enroll and follow a large, diverse IBD cohort • Efficient and inexpensive • Focus on patient-reported data: • Exposures (i.e. diet, medications, smoking) • Health behaviors (i.e. adherence, prevention) • Outcomes (i.e. fatigue, depression, anxiety, pain) • Provide a platform for ancillary studies: observational, interventional, translational
How it works • Enrolled >12,000 IBD patients from CCFA email rosters, CCFA web-page link, social media, walks, etc. • Baseline survey • Core module (medications, surgery, disease activity) • Optional modules • 6-month surveys to determine change in treatment or health status (optional modules) • Use 3-month contacts to deliver educational messages • Reminder about prevention activities such as flu vaccine, etc. • Enhance participation
Publications *submitted
What we have learned so far • Prevention - About half had a bone density scan or took calcium or vitamin D supplements. Only 40% reported having a skin exam and 16% reported always wearing sunscreen. Less than 2/3 had an flu vaccine. • Adherence – majority had adherence in low range; disease activity correlated with low adherence • Quality of life – worse QOL with more disease activity; better QOL in UC with colectomy • PROMIS - IBD patients had more anxiety, depression, fatigue and sleep disturbance, and less social satisfaction than the general population. Using corticosteroids made all of the outcomes worse. • Elderly depression - as many as 1 in 4 elderly patients with IBD may suffer from depression. Depressed elderly patients with IBD were more likely to have more severe disease activity and less likely to take their medication correctly all of the time • Sexual interest - women, patients with disease around their rectum and patients with more active disease had less sexual interest and satisfaction. Half of patients with ostomies said that their ostomy affected their sexual satisfaction.
Infographics Sharing results Lay summaries
Ancillary studies General categories • Analyses of existing data • Supplemental surveys (fertility, adverse med effects, infections) distributed to all participants or a subset (females only, age-restricted, prior surgery, etc) • Educational interventions – ‘ask your doctor about a flu shot’ • Recruitment for other studies (biospecimens, chart extraction, RCT) • Combination of above Varying assistance by DMC • Turn-key (form design, data management, data analysis, etc) • Independent investigator (DMC assists with subject selection, recruitment, prepares extract of CCFA Partners data) • Hybrid
Ancillary studies • AshwinAnanthakrishnan, MGH, Bidirectional Association Between Sleep and Disease Activity (abstract and accepted paper) • Frank Farraye, BU, Patient Vaccine Survey (abstract) • Joshua Korzenik, BWH, An Investigation into Diet and its Role with Exacerbations of Ulcerative Colitis • Gill Melmed, Cedars-Sinai, Sex Hormones on Disease Activity (abstracts) • Maria Ferris, UNC, The Role of Health Literacy, Social Support, Social Media and ADHD symptoms in Predicting Medication Adherence • Lawrence Gaines, Vanderbilt, Depression as a Risk Factor for Crohn’s • Balfour Sartor, UNC, Genetic Associations for Rare IBD phenotypes
FACES Food and Crohn’s Exacerbation Study James Lewis
Validity “On the Internet, nobody knows you’re a dog.”
CCFA Partners-GSK Validation Study Aim: To assess the validity of self-reported medical data in the CCFA Partners internet cohort Method: Compare specific aspects of self-reported IBD characteristics to information from treating physician, including: • Confirmation of IBD (not IBS or diverticulitis) • Type of IBD (Crohn’s disease or ulcerative colitis) • Location or extent of disease • Crohn’s disease behavior (stricturing or penetrating) • Extra-intestinal disease manifestations • Prior surgeries • Current pouch or ostomy
Biospecimens • Biorepository pilot • Assess willingness of respondents to provide genetic samples or other biospecimens • Establish infrastructure to collect, ship, store, and analyze genetic and fecal biospecimens • Compare feasibility and recruitment rates for different methods of sample collection
New directions • Data collection beyond surveys • Enhanced Patient Engagement • Increased enrollment • Improved retention
Enhanced patient engagement • Sharing of Research Findings • Involving Patients in Prioritization of Research Agenda • Patient Functionality • Social Networking/Community Building
Summary • Harness the power of the Internet to efficiently enroll and follow unprecedented numbers of IBD patients • Largest US study of the impact of IBD. Already enrolled subjects from all 50 states, 4 U.S. territories, urban and rural, cared for by private and academic GI’s • Help to advance methods in patient reported outcomes for clinical research and epidemiology • Platform to recruit for other studies (interventional, epidemiological, HSR, translational) • Beyond research, has the potential to impact patient lives through prevention messages and disease education.
