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

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ClinicalTrials.gov Identifier: NCT00620126
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis
Study Start Date : January 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Clinical Disease Activity (Seo Index) [ Time Frame: 12 months ]
    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.

  2. Quality of Life (IBDQ) [ Time Frame: 12 Months ]
    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.

  3. Percentage of Participants Adherent to Therapy [ Time Frame: 12 Months ]
    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".


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 & Education Foundation, Inc.
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 ( Other Grant/Funding Number: Broad Medical Research Program )
First Posted: February 21, 2008    Key Record Dates
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012
Last Verified: October 2012

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

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