Ulcerative Colitis Clinical Trial
— TELE-IBDOfficial title:
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Verified date | September 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 348 |
Est. completion date | September 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Agency for Healthcare Research and Quality (AHRQ), University of Pittsburgh, Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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