CCFA Partners: An Internet-based Cohort Study

Robert S. Sandler, MD, MPHUniversity of North Carolina

Chapel Hill, NC

Outline

Introduction – name, vision, who we areHow it worksEnrollment/retentionWhat we have learned so farSharing the resultsAncillary studiesValidation studyBiospecimen feasibilityNew directionsSummary

The name

CCFA

IBD patient community

UNC research team

CCFA partners research teamRobert 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

Core data

Baseline and Q6 month follow-up

Health care utilization

Smoking

IBD hospitalizations, surgery, cancer

Medications

NSAIDs

Family history of IBD

IBD history

Current disease activity

Prevention

Exercise

Quality of life-SIBDQ

Patient reported outcomes-PROMIS

Three month messages

Progress

Enrollment

Source of self-registered patients

Follow-up time

Maintaining participation

Important Results from CCFA Partners Patients helping patients... Thank you for joining the CCFA Partners community! Your continued participation is very important -- you are helping researchers understand and ultimately improve the lives of people with IBD. Our goal is to understand changes in lifestyle over time—that’s why it is so important for our Partners to complete an updated survey ever six months. Please click here to complete your [baseline / follow-up] survey today [only seen by those who have not]. Below are new findings about sleep and IBD flares from the Partners study. These findings would not have been possible without the help of Partners like you. With your continued participation we will be able to answer other questions that impact people with IBD.

We studied 3,173 IBD patients in Partners, among whom 1,798 were in clinical remission. Disease activity, depression, female gender, smoking, and use of corticosteroids or narcotics

were associated with sleep disturbance at enrollment. Among 1,291 Crohn’s disease patients in remission at baseline, those with impaired sleep

were twice as likely to relapse at 6 months.

You can read more about these results, as well as other publications from CCFA Partners under the Results tab at www.ccfapartners.org

CCFA Partners cares about your health! Tips for improving sleep hygiene:

Try to go to bed at the same time each day. Avoid using your bedroom to work, study or eat. Avoid watching TV before bedtime. Avoid coffee, tea and chocolate after 5 p.m. Avoid alcohol close to bedtime. Keep your room’s temperature comfortable. Noise and light can lead to poor sleep. Thus, try to sleep in a silent dark room Regular physical activity can improve the quality of your sleep. Establish a bedtime routine. A warm bath close to bedtime is recommended to fight insomnia. Sleep only the time sufficient for you to feel refreshed. Do not stay in bed

longer than necessary. When you can’t sleep, get up and do something boring or repetitive, such as

reading an uninteresting book.

References:

1. Ananthakrishnan AN, Long MD, Martin CF, Sandler RS, Kappelman MD. Sleep Disturbance and Risk of Active Disease in Patients with Crohn's Disease and Ulcerative Colitis. Clin Gastroenterol

Publications

Publications

Papers (7)

Cohort developmentDietary patternsGeriatric depressionPerceptions of care

Patient reported outcomesSleepVaccine beliefs

Abstracts (22)

Cohort developmentPreventionAdherenceQuality of lifeDietPatient reported outcomesPerceptions of chronic careDepressionBiobankingGlutenBehavioral interventions

ImmunizationsUpdate on cohortPrevention messagesValidationExerciseSleepPregnancyHormonesKids & TeensNSAIDSEmail prevention messages

*submitted

What we have learned so farPrevention - 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 adherenceQuality of life – worse QOL with more disease activity; better QOL in UC with colectomyPROMIS - 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 timeSexual 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.

Sharing results

InfographicsLay summaries

Ancillary studiesGeneral 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 studiesAshwin Ananthakrishnan, 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 StudyJames Lewis

Validity

“On the Internet, nobody knows you’re a dog.”

CCFA Partners-GSK Validation StudyAim: To assess the validity of self-reported medical data in the CCFA Partners internet cohortMethod: 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

CCFA Partners-GSK Validation Study

Compare physician information to participant self-reported information

Physician completes Validation Form online or by mail

Physician mailed Validation Form

Participant consents and provides information on treating physician

Participant mailed information, consent and HIPAA forms

CCFA Partners participant expresses interest in study

CCFA Partners-GSK Validation Study

CCFA Partners-GSK Validation Study3884

indicated interest

450 invited to participate

258 consented

(57%)

160 physician reports obtained

(62%)

5 no IBD(3%)

155 confirmed IBD

(97%)

7 disease type did not match

(5%)

148 disease type matched

(95%)

92 not returned4 physicians refused

2 physicians left practice

139 not returned (31%)47 refused (10%)

6 ineligible

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

Biospecimens

New directions

Data collection beyond surveysEnhanced Patient Engagement

● Increased enrollment● Improved retention

Digital future

mHealth use by CCFA Partners Cohort

mHealth app and device

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.

Summary