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

NCT01692743 | Completed Phase 3 Results DMC

• 1 other identifier: HP-00049230
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

Keywords

Telemedicine; Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Quality of life; Health care utilization

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Health Care Utilization

  One year

Study Arms (3)

Standard of Care

NO INTERVENTION

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.

Weekly Home Monitoring

EXPERIMENTAL

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

Home Monitoring Every Other Week

EXPERIMENTAL

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

Interventions

Home Monitoring BEHAVIORAL

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.

Weekly Home Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Pittsburgh: collaborator
• Vanderbilt University: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Cross RK, Jambaulikar G, Langenberg P, Tracy JK, Collins JF, Katz J, Regueiro M, Schwartz DA, Quinn CC. TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial. Contemp Clin Trials. 2015 May;42:132-44. doi: 10.1016/j.cct.2015.03.006. Epub 2015 Mar 24.

  PMID: 25812483 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Patient Acceptance of Health Care

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Raymond K. Cross, MD, MS, AGAF
• Organization: University of Maryland School of Medicine

rcross@som.umaryland.edu

410-706-3387

Study Officials

• Raymond K Cross, MD, MS, AGAF

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 25, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2016
• Last Updated: September 16, 2019
• Results First Posted: April 17, 2019

Record last verified: 2019-09

Locations

US (1)