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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Vanderbilt University | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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Improved methods are needed to monitor patients with inflammatory bowel disease. Telemedicine has shown promise in patients with other chronic diseases; pilot testing in our patients with inflammatory bowel disease demonstrated that the technology was feasible and improved clinical outcomes.
The telemedicine system for patients with inflammatory bowel disease (Tele-IBD) should improve outcomes for patients, improve access to care in areas with limited resources, and decrease health care costs.
Introduction: Inflammatory bowel disease (IBD) is a chronic condition that results in debilitating symptoms. Although effective treatments exist, inadequate monitoring of symptoms and side effects, nonadherence, and poor patient knowledge are barriers to success. Telemedicine has been used in other chronic diseases to improve outcomes; pilot testing of telemedicine demonstrated that it is feasible and accepted in IBD. Our preliminary results from a randomized trial in participants with ulcerative colitis showed significant improvements in quality of life from baseline to one year in the telemanagement group.
Study Design: Telemedicine for Patients with Inflammatory Bowel Disease (Tele-IBD) is a 12-month, multicenter, randomized, controlled trial to assess the impact of Tele-IBD compared to standard care in participants with IBD. The aims of the study are to: (1) assess disease activity in participants with IBD using Tele-IBD compared to participants using standard care, (2) assess quality of life in participants with IBD using Tele-IBD compared to participants using standard care, and (3) estimate differences of person-level rates of utilization of health care resources in participants with IBD using Tele-IBD compared to participants using standard care.
Methods: Tele-IBD consists of a web-portal and a weight scale. Participants answer questions about IBD symptoms, side effects and adherence using their home PC or a laptop with wireless Internet access provided to them for the study. A series of educational topics is administered via video messaging every 2-3 weeks. Tele-IBD participants complete self-testing weekly or every other week; the results are immediately available on the web-portal for review. Based on the responses, alerts and action plans are created for each participant. A nurse care coordinator consults the participant's medical provider for management changes if necessary. IBD patients evaluated at the University of Maryland, Baltimore, University of Pittsburgh, and Vanderbilt University will be invited to participate. Interested patients will be randomized in a 1:1:1 fashion to receive Tele-IBD weekly, Tele-IBD every other week, or standard care. Disease activity, quality of life, medical adherence, and utilization of health care resources will be assessed every 6 months for one year. In addition, provider interactions with patients in all three arms will be monitored and recorded.
Expected Findings: Tele-IBD will decrease disease activity and improve quality of life through improved adherence and monitoring of symptoms, earlier and more effective implementation of therapy, more frequent patient-provider interactions, and improved patient self-management. Better control of IBD will result in decreased utilization of health care resources.
Significance: If Tele-IBD improves outcomes, it is likely to be used to improve IBD care, to contain health care costs, to increase access to care, and to improve adherence with physician performance measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America. | |
| Weekly Home Monitoring | Experimental | Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
|
| Home Monitoring Every Other Week | Experimental | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Monitoring | Behavioral | Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
| Measure | Description | Time Frame |
|---|---|---|
| Harvey Bradshaw Index | Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools. | 12 months |
| Inflammatory Bowel Disease Questionnaire | Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1]. Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores >168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Utilization | Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out) | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond K Cross, MD, MS, AGAF | University of Maryland, College Park | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25812483 | Derived | Cross RK, Jambaulikar G, Langenberg P, Tracy JK, Collins JF, Katz J, Regueiro M, Schwartz DA, Quinn CC. TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial. Contemp Clin Trials. 2015 May;42:132-44. doi: 10.1016/j.cct.2015.03.006. Epub 2015 Mar 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America. |
| FG001 | Weekly Home Monitoring | Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
| FG002 | Home Monitoring Every Other Week | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America. |
| BG001 | Weekly Home Monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Harvey Bradshaw Index | Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools. | Crohn's disease population | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Participants undergo usual follow up (routine and as needed office visits and telephone calls) and receive educational fact sheets from the Crohn's and Colitis Foundation of America. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond K. Cross, MD, MS, AGAF | University of Maryland School of Medicine | 410-706-3387 | rcross@som.umaryland.edu |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Home Monitoring | Behavioral | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
|
Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
| BG002 | Home Monitoring Every Other Week | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Quality of Life (IBDQ) | The Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32-224, with higher scores indicating greater disease-specific quality of life. An IBDQ score of greater than 168 has been shown to correlate with clinical remission in patients with Crohn's disease. Further, scores of 16 to 32 have been found to be significant changes when compared to baseline values. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Weekly Home Monitoring | Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
| OG002 | Home Monitoring Every Other Week | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. |
|
|
| Primary | Inflammatory Bowel Disease Questionnaire | Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1]. Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional. Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores >168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant. | IBDQ Scores | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Health Care Utilization | Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out) | Posted | Number | Encounters | One year |
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Weekly Home Monitoring | Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. | 0 | 116 | 0 | 116 | 0 | 116 |
| EG002 | Home Monitoring Every Other Week | Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. Home Monitoring: Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met. | 0 | 115 | 0 | 115 | 0 | 115 |
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| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |