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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:
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
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title UC Home Automated Telemanagement Best Available Care
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 25 22
Completed 14 17
Not Completed 11 5
Arm/Group Title Intervention Control Total
Hide Arm/Group Description UC Home Automated Telemanagement Best Available Care Total of all reporting groups
Overall Number of Baseline Participants 25 22 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 22 participants 47 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
  92.0%
21
  95.5%
44
  93.6%
>=65 years
2
   8.0%
1
   4.5%
3
   6.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 22 participants 47 participants
41.7  (13.9) 40.3  (13.9) 41.1  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 22 participants 47 participants
Female
15
  60.0%
15
  68.2%
30
  63.8%
Male
10
  40.0%
7
  31.8%
17
  36.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 22 participants 47 participants
25 22 47
1.Primary Outcome
Title Clinical Disease Activity (Seo Index)
Hide Description 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
UC Home Automated Telemanagement
Best Available Care
Overall Number of Participants Analyzed 25 22
Mean (Standard Deviation)
Unit of Measure: Units
122  (39.3) 113.6  (28)
2.Primary Outcome
Title Quality of Life (IBDQ)
Hide Description 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.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
UC Home Automated Telemanagement
Best Available Care
Overall Number of Participants Analyzed 25 22
Mean (Standard Deviation)
Unit of Measure: Units
178.1  (32.1) 187.3  (32.2)
3.Primary Outcome
Title Percentage of Participants Adherent to Therapy
Hide Description 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”.
Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
UC Home Automated Telemanagement
Best Available Care
Overall Number of Participants Analyzed 25 22
Measure Type: Number
Unit of Measure: Percentage of Participants
57 67
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description UC Home Automated Telemanagement Best Available Care
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/22 (0.00%) 
  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
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
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