Phase 3
N=348
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Inflammatory Bowel Disease · Crohn's Disease · Ulcerative Colitis · Indeterminate Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01692743 ↗Enrolled (actual)
348
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Harvey Bradshaw Index — 3.7; 3.2; 4.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Home Monitoring (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Harvey Bradshaw Index |
3.7; 3.2; 4.2 | — |
| PRIMARY Inflammatory Bowel Disease Questionnaire |
179.3; 179.2; 181.5 | — |
| SECONDARY Health Care Utilization |
2435; 2167; 2481 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01692743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.