Trial record 1 of 1 for:    tele-ibd
Previous Study | Return to List | Next Study

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
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Behavioral: Home Monitoring
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telemedicine in Patients With Inflammatory Bowel Disease (TELE-IBD)

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Health Care Utilization [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692743

Contacts
Contact: Guru Jambaulikar, MBBS, MPH 410-706-3397 gjambaulikar@medicine.umaryland.edu
Contact: Katherine Osche-Gauvin 410-706-5943 kosche@medicine.umaryland.edu

Locations
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Guru Jambaulikar, MBBS, MPH    410-706-3397    gjambaulikar@medicine.umaryland.edu   
Principal Investigator: Raymond Cross, MD, MS         
Sponsors and Collaborators
University of Maryland
University of Pittsburgh
Vanderbilt University
Investigators
Principal Investigator: Raymond K Cross, MD, MS, AGAF University of Maryland
  More Information

No publications provided

Responsible Party: Raymond Cross, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01692743     History of Changes
Other Study ID Numbers: HP-00049230
Study First Received: September 13, 2012
Last Updated: November 4, 2013
Health Authority: United States: Agency for Healthcare Research and Quality

Keywords provided by University of Maryland:
Telemedicine
Inflammatory bowel disease
Crohn's disease
Ulcerative colitis
Quality of life
Health care utilization

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014