Phase 3
Completed N=348
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Source: ClinicalTrials.gov NCT01692743 ↗Enrolled (actual)
348
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Harvey Bradshaw Index — 3.7; 3.2; 4.2 units on a scale
◆ Published Evidence
Established
61citations · ~6 / year
TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial.
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.
Linked Publications
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TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.