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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
The Broad Foundation
Baltimore Research & Education Foundation, Inc.
Baltimore VA Medical Center
Information provided by (Responsible Party):
Raymond Cross, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Inflammatory Bowel Disease
Ulcerative Colitis
Interventions: Other: UC Home Automated Telemanagement
Other: Best Available Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
UC Home Automated Telemanagement The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
Best Available Care The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn’s and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.

Participant Flow:   Overall Study
    UC Home Automated Telemanagement   Best Available Care
STARTED   25   22 
COMPLETED   14   17 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Intervention UC Home Automated Telemanagement
Control Best Available Care
Total Total of all reporting groups

Baseline Measures
   Intervention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   22   47 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   23   21   44 
>=65 years   2   1   3 
[Units: Years]
Mean (Standard Deviation)
 41.7  (13.9)   40.3  (13.9)   41.1  (14) 
[Units: Participants]
Female   15   15   30 
Male   10   7   17 
Region of Enrollment 
[Units: Participants]
United States   25   22   47 

  Outcome Measures

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

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

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  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

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: PI
Organization: University of Maryland. Baltimore
phone: 410-706-3387
e-mail: rcross@medicine.umaryland.edu


Responsible Party: Raymond Cross, 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 Submitted: February 8, 2008
First Posted: February 21, 2008
Results First Submitted: August 13, 2011
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012