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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Maryland
Sponsor:
Collaborators:
University of Pittsburgh
Vanderbilt University
Information provided by (Responsible Party):
Raymond Cross, University of Maryland
ClinicalTrials.gov Identifier:
NCT01692743
First received: September 13, 2012
Last updated: November 4, 2013
Last verified: November 2013

September 13, 2012
November 4, 2013
September 2012
October 2015   (final data collection date for primary outcome measure)
  • Disease Activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical disease activity
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disease-specific quality of life (inflammatory bowel disease questionnaire)
Same as current
Complete list of historical versions of study NCT01692743 on ClinicalTrials.gov Archive Site
Health Care Utilization [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)
Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Ulcerative Colitis
  • Indeterminate Colitis
  • Behavioral: Home Monitoring
    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
    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.
  • No Intervention: Standard of Care
    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
    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.
    Intervention: Behavioral: Home Monitoring
  • Experimental: Home Monitoring Every Other Week
    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.
    Intervention: Behavioral: Home Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
375
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Guru Jambaulikar, MBBS, MPH 410-706-3397 gjambaulikar@medicine.umaryland.edu
Contact: Katherine Osche-Gauvin 410-706-5943 kosche@medicine.umaryland.edu
United States
 
NCT01692743
HP-00049230
No
Raymond Cross, University of Maryland
University of Maryland
  • University of Pittsburgh
  • Vanderbilt University
  • Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Raymond K Cross, MD, MS, AGAF University of Maryland
University of Maryland
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP