Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)

Introduction: Inflammatory bowel disease (IBD) is a chronic condition that results in
debilitating symptoms. Although effective treatments exist, inadequate monitoring of symptoms
and side effects, nonadherence, and poor patient knowledge are barriers to success.
Telemedicine has been used in other chronic diseases to improve outcomes; pilot testing of
telemedicine demonstrated that it is feasible and accepted in IBD. Our preliminary results
from a randomized trial in participants with ulcerative colitis showed significant
improvements in quality of life from baseline to one year in the telemanagement group.

Study Design: Telemedicine for Patients with Inflammatory Bowel Disease (Tele-IBD) is a
12-month, multicenter, randomized, controlled trial to assess the impact of Tele-IBD compared
to standard care in participants with IBD. The aims of the study are to: (1) assess disease
activity in participants with IBD using Tele-IBD compared to participants using standard
care, (2) assess quality of life in participants with IBD using Tele-IBD compared to
participants using standard care, and (3) estimate differences of person-level rates of
utilization of health care resources in participants with IBD using Tele-IBD compared to
participants using standard care.

Methods: Tele-IBD consists of a web-portal and a weight scale. Participants answer questions
about IBD symptoms, side effects and adherence using their home PC or a laptop with wireless
Internet access provided to them for the study. A series of educational topics is
administered via video messaging every 2-3 weeks. Tele-IBD participants complete self-testing
weekly or every other week; the results are immediately available on the web-portal for
review. Based on the responses, alerts and action plans are created for each participant. A
nurse care coordinator consults the participant's medical provider for management changes if
necessary. IBD patients evaluated at the University of Maryland, Baltimore, University of
Pittsburgh, and Vanderbilt University will be invited to participate. Interested patients
will be randomized in a 1:1:1 fashion to receive Tele-IBD weekly, Tele-IBD every other week,
or standard care. Disease activity, quality of life, medical adherence, and utilization of
health care resources will be assessed every 6 months for one year. In addition, provider
interactions with patients in all three arms will be monitored and recorded.

Expected Findings: Tele-IBD will decrease disease activity and improve quality of life
through improved adherence and monitoring of symptoms, earlier and more effective
implementation of therapy, more frequent patient-provider interactions, and improved patient
self-management. Better control of IBD will result in decreased utilization of health care
resources.

Significance: If Tele-IBD improves outcomes, it is likely to be used to improve IBD care, to
contain health care costs, to increase access to care, and to improve adherence with
physician performance measures.

Inclusion Criteria:

- Confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis

Exclusion Criteria:

- Cannot comprehend simple instructions in English

- Inability to comply with the study protocol (i.e., active drug or alcohol abuse or
history of nonadherence to medical visits and/or medications)

- Presence of an ileostomy, colostomy, ileoanal j pouch anastomosis or ileorectal
anastomosis

- Imminent surgery

- History of short bowel syndrome

- No flares of disease in last two years

- Uncontrolled medical or psychiatric disease Degenerative neurologic condition Unstable
angina Class III/IV congestive heart failure Severe asthma or chronic obstructive
pulmonary disease Symptomatic peripheral vascular disease Chronic renal insufficiency
(creatinine > 2.0) Malignancy within the last 5 years (excluding squamous or basal
cell cancers of the skin) Poorly controlled depression, mania, and schizophrenia
Active infection Acquired immunodeficiency syndrome

- Pregnancy

- Age less than 18 years.