Scientific Abstract
Proposal No. IBD-0190
Principal Investigator: Raymond K. Cross, M.D.
Applicant Organization: University of Maryland (Baltimore, U.S.A.)
Project Title: Home telemanagement trial (UC HAT) in patients with ulcerative colitis
Period of Award: October 1, 2006 – June 30, 2010
Introduction: Ulcerative colitis (UC) is a chronic inflammatory disease needing monitoring of symptoms, medication side effects, and adherence to medical therapy. Poor patient knowledge of the disease is a barrier to successful outcomes. Telemanagement has improved outcomes in other chronic diseases; pilot testing in our patients with inflammatory bowel disease demonstrated that applying this technology to UC is feasible and accepted by patients. Further, we showed that telemanagement improves patient knowledge, decreases disease activity, and improves quality of life.
Study Design: The Home Telemanagement Trial (UC HAT) in Patients with UC is a 12-month randomized controlled trial to assess the impact of UC HAT compared to routine care in patients with UC. Our central hypothesis is that compared to routine UC care, UC HAT will decrease clinical disease activity, improve disease-specific quality of life, promote medical adherence, and decrease utilization of health care resources. The aims of the study are:
1. To compare disease activity in patients using UC HAT with routine care controls.
a. To compare the difference in Seo index scores in patients using UC HAT with routine care controls
b. To compare the difference in the sedimentation rate, C reactive protein, and platelet count in patients using UC HAT with routine care controls
2. To compare disease-specific quality of life in patients using UC HAT with routine care controls.
3. To compare medical adherence in patients using UC HAT with routine care controls.
a. To compare the difference in adherence as measured by pill counts in patients using UC HAT with routine care controls
b. To compare the difference in Morisky Medication Adherence Scores in patients using UC HAT with routine care controls
4. To compare utilization of health care resources in patients using UC HAT with routine care controls (Exploratory).
a.To compare the difference in urgent care visits in patients using UC HAT with routine care controls
b. To compare the difference in hospitalization rates in patients using UC HAT with routine care controls
c. To compare the difference in length of stay in patients using UC HAT with routine care controls
Methods: UC HAT consists of a laptop computer, an electronic weight scale, and a web portal. Patients answer questions about UC symptoms, side effects and medication adherence using the laptop. Body weight is automatically downloaded to the laptop after the weight is measured. An educational curriculum is administered at the end of each session. The results from self-testing are downloaded to a secure server for review. Based on the responses, alerts and action plans are generated for each patient. The nurse coordinator can consult the patient’s medical provider for management changes for the patient if necessary. UC patients evaluated at the University of Maryland and the VA, Baltimore will be invited to participate. Interested patients will be randomized to either the UC HAT or routine care groups. Patients assigned to the routine care group will undergo scheduled follow up visits, telephone follow up calls, and receive educational fact sheets about the disease. Patients assigned to the UC HAT group will undergo self-testing weekly using the telemanagement system while continuing to receive routine care. Clinical disease activity, disease-specific quality of life, medical adherence, and utilization of health care resources will be assessed every 3 months for one year in all patients.
Expected Findings: UC HAT will improve medical adherence and monitoring of disease symptoms and medication side effects; this will result in decreased disease activity and improved quality of life as well as decreased utilization of health care resources.
Significance: If UC HAT improves care in patients with UC, the technology may be applied outside of the research setting for all patients to improve outcomes or for selected populations of patients with UC to improve access to care.