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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by University of Maryland. Recruitment status was Active, not recruiting

First Received on February 8, 2008. Last Updated on April 3, 2009 History of Changes

Sponsor:	University of Maryland
Collaborators:	The Broad Foundation Baltimore Research and Education Foundation Baltimore VA Medical Center
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00620126

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 Telemedicine	Other: UC Home Automated Telemanagement Other: Best Available Care	Phase III

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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Clinical Disease Activity (Seo Index) [ Time Frame: Q 4 Months ] [ Designated as safety issue: No ]
Quality of Life (IBDQ) [ Time Frame: Q 4 Months ] [ Designated as safety issue: No ]
Adherence (MMAS and Pharmacy Refill Data) [ Time Frame: Q 4 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Utilization of Health Care Resources (Urgent care visits, hospitalizations, and length of stay) [ Time Frame: Q 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 UC Home Automated Telemanagement	Other: UC Home Automated Telemanagement Weekly assessment with UC Home Automated Telemanagement
Active Comparator: 2 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

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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:

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.

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. Epub 2007 Jan 9.

Responsible Party:	Raymond Cross/PI, University of Maryland
ClinicalTrials.gov Identifier:	NCT00620126 History of Changes
Other Study ID Numbers:	H-27882, IBD-0190
Study First Received:	February 8, 2008
Last Updated:	April 3, 2009
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 February 09, 2012