Ignite Creation Date:
2024-05-06 @ 12:57 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01692743
Status:
COMPLETED
Last Update Posted:
2019-09-16
First Post:
2012-09-13
Brief Title:
Telemedicine in Patients With Inflammatory Bowel Disease TELE-IBD
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Telemedicine in Patients With Inflammatory Bowel Disease TELE-IBD
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-IBD
Brief Summary:
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
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
Detailed Description:
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 participants 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 111 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
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 participants 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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None