Trial Outcomes & Findings for The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis (NCT NCT00620126)
NCT ID: NCT00620126
Last Updated: 2019-11-13
Results Overview
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.
COMPLETED
PHASE3
47 participants
12 months
2019-11-13
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
|
Overall Study
COMPLETED
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Intervention
n=25 Participants
UC Home Automated Telemanagement
|
Control
n=22 Participants
Best Available Care
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 13.9 • n=39 Participants
|
40.3 years
STANDARD_DEVIATION 13.9 • n=41 Participants
|
41.1 years
STANDARD_DEVIATION 14 • n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=39 Participants
|
22 participants
n=41 Participants
|
47 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 monthsClinical 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.
Outcome measures
| Measure |
Intervention
n=25 Participants
UC Home Automated Telemanagement
|
Control
n=22 Participants
Best Available Care
|
|---|---|---|
|
Clinical Disease Activity (Seo Index)
|
122 Units
Standard Deviation 39.3
|
113.6 Units
Standard Deviation 28
|
PRIMARY outcome
Timeframe: 12 MonthsDisease-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.
Outcome measures
| Measure |
Intervention
n=25 Participants
UC Home Automated Telemanagement
|
Control
n=22 Participants
Best Available Care
|
|---|---|---|
|
Quality of Life (IBDQ)
|
178.1 Units
Standard Deviation 32.1
|
187.3 Units
Standard Deviation 32.2
|
PRIMARY outcome
Timeframe: 12 MonthsAdherence 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".
Outcome measures
| Measure |
Intervention
n=25 Participants
UC Home Automated Telemanagement
|
Control
n=22 Participants
Best Available Care
|
|---|---|---|
|
Percentage of Participants Adherent to Therapy
|
57 Percentage of Participants
|
67 Percentage of Participants
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place