Kidney Transplantation Clinical Trial
Official title:
Predictors and Intervention for Noncompliance
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.
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. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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