The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Ulcerative colitis (UC) is a common inflammatory condition of the bowels that results in bloody diarrhea, abdominal pain, and lack of control of bowel movements. UC is a chronic medical condition that causes frequent episodes of symptoms (flares) followed by symptom-free intervals. Although drugs are available to treat the symptoms, there are obstacles to successful treatment. Because patients need to take medications continuously to avoid flares, compliance with drugs can difficult. Monitoring the symptoms of UC is also challenging, because flares are sporadic and often do not occur at the time of routine office visits. This can result in treatment delays. Although the drugs used to treat colitis are effective, they have side effects which can decrease compliance and quality of life. Patient's knowledge of the disease can also be poor, which can affect many aspects of care. Telemanagement systems are telemedicine systems that are designed to (1) assist physicians in monitoring their patients, (2) assist physicians in following current guidelines, (3) help patients follow self-care plans, and (4) deliver educational facts to patients. Telemedicine systems have been used in diseases similar to UC and have improved outcomes. We designed a telemanagement system specifically for patients with inflammatory bowel disease (IBD HAT) and found that IBD HAT was easy to use, was accepted by patients, and improved various aspects of patient care including patient knowledge, quality of life, and bowel symptoms. The purpose of the study is to determine if a home telemanagement system for patients with UC (UC HAT) improves clinical outcomes compared to routine care. Patients with UC will be identified from the University of Maryland IBD program and the gastroenterology clinic of the VA Maryland Health Care System, Baltimore. A computer program will assign interested patients by chance to either the UC HAT or the routine care group. Patients in the UC HAT group will be asked to complete self-testing each week at home using the system. The home-unit consists of a laptop computer and electronic weight scale. After turning on the computer, patients answer questions about their bowel symptoms, medication side effects, and compliance with medications. The home-unit then prompts subjects to measure their weight on the scale. Subjects then receive an educational tip of the day. The following session, subjects answer an educational question that relates to the tip. After self-testing is completed, the results are transmitted via a phone line to our secure server. The results are made available immediately for review on the physician's web portal. Based on the responses to the symptom diary, side effect questions, medical compliance, and body weight, electronic alerts and action plans can be generated. An alert is sent electronically to the study coordinator, who then reviews the information and discusses the findings with the principal investigator and the patient's medical provider. Changes in patient management can be made if appropriate. An action plan is created for each patient at the first visit and contains a list of tasks for patients to start immediately after self-testing if certain criteria are met. Patients still undergo regularly scheduled clinical visits as prescribed by their medical provider. Patients assigned to the routine care group will undergo scheduled follow up clinical visits, telephone follow up, and receive educational fact sheets about their disease. This is considered routine care at our centers. All patients will undergo research visits every 3 months for one year. Patients will complete a series of questionnaires at each visit that measure the patient's disease activity, quality of life, IBD knowledge, medical compliance, and other parameters. Emergency room visits and hospitalizations will also be measured. A blood draw is required at each study visit. We think that UC HAT will improve the monitoring of bowel symptoms and medication side effects and improve medical compliance. These improvements should result in decreased bowel symptoms, improved quality of life, and decreased urgent care visits and hospitalizations. If UC HAT is effective, the system could be used in the IBD community to improve clinical care or be used in patients with limited access to health care.

Official Title
-----------------
The Home Telemanagement (UC HAT) Trial for Patients With Ulcerative Colitis

Conditions
-----------------
Inflammatory Bowel Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: UC Home Automated Telemanagement
* Other: Best Available Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>UC Home Automated Telemanagement | Other: UC Home Automated Telemanagement<br>* Weekly assessment with UC Home Automated Telemanagement<br>|
| Active Comparator: Control<br>Best Available Care | Other: Best Available Care<br>* Routine follow up visits and as needed telephone calls and clinic visits, written action plans, educational fact sheets from the CCFA<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Disease Activity (Seo Index) | 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. | 12 months | 
| Quality of Life (IBDQ) | 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. | 12 Months | 
| Percentage of Participants Adherent to Therapy | 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. | 12 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory bowel disease, Ulcerative colitis, Telemedicine, Telemanagement, Chronic disease