Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Home Monitoring; Home Monitoring
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Telemedicine; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Quality of life; Health care utilization

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.
    

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.