Clinical trial NCT01692743: Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Official title: Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Keywords: Telemedicine
Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Quality of life
Health care utilization
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Vanderbilt University
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-09-25
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine has shown promise in patients with other chronic diseases; pilot testing in our patients with inflammatory bowel disease demonstrated that the technology was feasible and improved clinical outcomes.

The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should improve outcomes for patients, improve access to care in areas with limited resources, and decrease health care costs.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Harvey Bradshaw Index
timeFrame: 12 months
measure: Inflammatory Bowel Disease Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Health Care Utilization
timeFrame: One year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Raymond K Cross, MD, MS, AGAF
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cross RK, Jambaulikar G, Langenberg P, Tracy JK, Collins JF, Katz J, Regueiro M, Schwartz DA, Quinn CC. TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial. Contemp Clin Trials. 2015 May;42:132-44. doi: 10.1016/j.cct.2015.03.006. Epub 2015 Mar 24.