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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis

Intervention / Treatment
-----------------
* Behavioral: Home Monitoring
* Behavioral: Home Monitoring


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America. | |
| Experimental: Weekly Home Monitoring<br>Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. | Behavioral: Home Monitoring<br>* Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.<br>|
| Experimental: Home Monitoring Every Other Week<br>Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. | Behavioral: Home Monitoring<br>* Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvey Bradshaw Index | Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools. | 12 months | 
| Inflammatory Bowel Disease Questionnaire | Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1]. Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores >168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Care Utilization | Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out) | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemedicine, Inflammatory bowel disease, Crohn's disease, Ulcerative colitis, Quality of life, Health care utilization