This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Home Telemanagement Trial in Patients with Ulcerative Colitis is a randomized clinical trial testing the efficacy of home telemanagement versus standard-of-care treatment in individuals with UC. Study participants will include adult outpatients with either active UC or UC in remission evaluated at the University of Maryland Inflammatory Bowel Disease (IBD) program and the gastroenterology clinic at the Veterans Affairs, Maryland Health Care System, Baltimore. Remission will be defined by a score of <120 on the Complex Index of Disease Activity (Seo index). The primary outcome will be the difference in scores between groups in the Seo Index at the 12-month follow-up visit. A decrease in the index of 35 points or more has been defined as clinical improvement. Further, rates of remission will be compared between groups using the Seo index. Secondary outcomes will include changes in the disease specific quality of life (IBDQ), the general quality of life (SF-36), laboratory parameters, and adherence as measured by pill counts and the Morisky Medication Adherence Scale (MMAS). Other secondary outcomes will include the change in patient knowledge of disease as measured by the Crohn's and Colitis Knowledge Score, in depression scores, in the Rating Form of IBD Patient Concerns scores, in client satisfaction scores, and in patient-physician discordance scores. Exploratory outcomes to be assessed will include the differences in rates of urgent care visits, hospitalizations, and length of hospital stays. The trial will use simple randomization to compare the effect of home telemanagement versus routine care in patients with UC. Telemanagement systems assist practitioners in following practice guidelines and in monitoring patients. Further, they help patients follow action plans and they can deliver an education curriculum to patients. The home telemanagement system for UC consists of a laptop computer and a weight scale connected via a phone line in the patient's home to the Chronic Disease Informatics Study Group Server for review by the research staff. Disease profiles are created for each subject on the physician's viewing page;the information is transmitted automatically to the subject's home telemanagement unit. Subjects answer questions about disease symptoms, medication side effects, and medication adherence using the laptop. The system then prompts subjects to measure their weight. Educational materials are delivered at the end of the study in the form of a question of the day. Results are transmitted via a phone line to a secure server. Responses are available for review by the research staff and providers;the provider can then change the patient's treatment if indicated. A list of all subjects with UC treated at the University of Maryland IBD Program and the gastroenterology clinic at the Veterans Affairs, Maryland Health Care System, Baltimore from 2004-2005 will be identified using the ICD-9 code 556 for ulcerative colitis. Inclusion and exclusion criteria are listed in the full IRB protocol. Information available in the patient's medical record at the time of the last follow up visit was used to determine eligibility. Individuals that meet the eligibility criteria will be randomized to either the intervention or routine care group if they agree to participate using a computerized random number generator. Our goal is to enroll 40 patients per group for a total of 80 subjects. Recruitment will end after 80 patients have been enrolled. Informed consent will be obtained at the baseline visit and the subject will complete a series of questionnaires, including assessment of the disease activity, laboratory parameters, quality of life, medication adherence, psychometric variables, and health utilization. Follow up visits will take place every three months for one year and will consist of the same series of laboratories and questionnaires and will be performed by an investigator blinded to the group assignment.
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