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

This study has been completed.
Sponsor:
Collaborators:
The Broad Foundation
Baltimore Research and Education Foundation
Baltimore VA Medical Center
Information provided by (Responsible Party):
Raymond Cross, University of Maryland
ClinicalTrials.gov Identifier:
NCT00620126
First received: February 8, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
 Other: UC Home Automated Telemanagement
Other: Best Available Care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Clinical Disease Activity (Seo Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Quality of Life (IBDQ) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Adherent to Therapy [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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".


Enrollment: 47
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
UC Home Automated Telemanagement
 Other: UC Home Automated Telemanagement
Weekly assessment with UC Home Automated Telemanagement
Active Comparator: Control
Best Available Care
 Other: Best Available Care
Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620126

Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
University of Maryland
The Broad Foundation
Baltimore Research and Education Foundation
Baltimore VA Medical Center
Investigators
Principal Investigator: Raymond K Cross, MD,MS University of Maryland
  More Information

Publications:

Responsible Party: Raymond Cross, Associate Professor of Medicine, University of Maryland
ClinicalTrials.gov Identifier: NCT00620126     History of Changes
Other Study ID Numbers: H-27882, IBD-0190
Study First Received: February 8, 2008
Results First Received: August 13, 2011
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Inflammatory bowel disease
Ulcerative colitis
Telemedicine
Telemanagement
Chronic disease

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

ClinicalTrials.gov processed this record on May 23, 2013