The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis

NCT00620126 | Completed Phase 3 Results

• 2 other identifiers: H-27882IBD-0190
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if home automated telemanagement improves bowel symptoms, quality of life, compliance with medications, and health care utilization compared to best available care in patients with ulcerative colitis.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis

Keywords

Inflammatory bowel disease; Ulcerative colitis; Telemedicine; Telemanagement; Chronic disease

Outcome Measures

Primary Outcomes (3)

• Clinical Disease Activity (Seo Index)

  Clinical disease activity was assessed using the Seo index. An activity index \<120 represents clinical remission, whereas scores of 121-150, 151-220, and \>221 correlate with mild, moderate, and severe disease respectively. The Seo index is sensitive to change, with a decrease in the index of 35 correlating with a clinical response.

  12 months

• Quality of Life (IBDQ)

  Disease-specific quality of life was assessed using the IBD questionnaire (IBDQ). Scores for the IBDQ range from 32 to 224 with higher scores being associated with better quality of life. Score changes of 16 have been found to be significant changes when compared to baseline values.

  12 Months

• Percentage of Participants Adherent to Therapy

  Adherence was assessed using the Morisky Medication Adherence Score, a 4 item survey in which participants self-report medication-taking behavior. Each question that is answered with a No receives a score of 1. The possible scoring range is therefore 0 to 4. Higher scores correlate with better medical adherence. For the purpose of evaluating percent of participants adherent to therapy, the variable was dichotomized to "Adherent" or "Non-adherent". Any response of Yes to one of the 4 items was scored as "Non-Adherent".

  12 Months

Study Arms (2)

Intervention

EXPERIMENTAL

UC Home Automated Telemanagement

Other: UC Home Automated Telemanagement

Control

ACTIVE COMPARATOR

Best Available Care

Other: Best Available Care

Interventions

UC Home Automated Telemanagement OTHER

Weekly assessment with UC Home Automated Telemanagement

Intervention

Best Available Care OTHER

Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA

Control

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ulcerative colitis confirmed by standard clinical, endoscopic, and histologic criteria

You may not qualify if:

• Inability to comply with the study protocol
• Previous colectomy with ileostomy or colectomy with ileoanal anastomosis
• History of colonic dysplasia or colorectal cancer
• Uncontrolled medical or psychiatric disease
• Unable or unwilling to provide consent
• Age less than 18 years
• Other forms of colitis

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• The Broad Foundation: collaborator
• University of Maryland, College Park: collaborator
• Baltimore Research & Education Foundation, Inc.: collaborator
• Baltimore VA Medical Center: collaborator

Study Sites (2)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Medical Institute

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• Cross RK, Arora M, Finkelstein J. Acceptance of telemanagement is high in patients with inflammatory bowel disease. J Clin Gastroenterol. 2006 Mar;40(3):200-8. doi: 10.1097/00004836-200603000-00006.

  PMID: 16633120 BACKGROUND

• Cross RK, Finkelstein J. Feasibility and acceptance of a home telemanagement system in patients with inflammatory bowel disease: a 6-month pilot study. Dig Dis Sci. 2007 Feb;52(2):357-64. doi: 10.1007/s10620-006-9523-4. Epub 2007 Jan 9.

  PMID: 17211702 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Chronic Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Insufficient sample size to detect moderate differences in outcomes between arms 2. Differences between groups at baseline may have resulted in no overall difference between arms at one year 3. Higher rate of attrition than expected

Results Point of Contact

• Title: PI
• Organization: University of Maryland. Baltimore

rcross@medicine.umaryland.edu

410-706-3387

Study Officials

• Raymond K Cross, MD,MS

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 13, 2019
• Results First Posted: October 11, 2012

Record last verified: 2019-11

Locations

US (2)