Phase 3
Completed N=47
The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis
Source: ClinicalTrials.gov NCT00620126 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Clinical Disease Activity (Seo Index) — 122; 113.6 Units
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Disease Activity (Seo Index) |
122; 113.6 | — |
| PRIMARY Quality of Life (IBDQ) |
178.1; 187.3 | — |
| PRIMARY Percentage of Participants Adherent to Therapy |
57; 67 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00620126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.