Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148174
Status:
COMPLETED
Last Update Posted:
2015-06-01
First Post:
2005-09-02
Brief Title:
Predictors and Intervention for Noncompliance
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Predictors and Intervention for Noncompliance
Status:
COMPLETED
Status Verified Date:
2015-05
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:
None
Brief Summary:
This is a randomized controlled intervention trial in poorly compliant patients testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss
Hypothesis A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss
Hypothesis A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss
Detailed Description:
Our original studies demonstrated early noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss In this study we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients Standard therapy includes specifically warning patients about the risks of noncompliant behavior and the formal intervention is randomized so half of these patients will also receive intensive telephone followup intended to improve medication compliance and reduce adverse events
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2P01DK013083-40A1 | NIH | None | httpsreporternihgovquickSearch2P01DK013083-40A1 |