Improving Long-Term Successful Outcome after Renal Transplantation: A Randomized Controlled Trial to Decrease Subclinical Noncompliance
Noncompliance with the immunosuppressive regimen is recongnized as an important cause of late graft loss in renal transplant recipients.
The purpose of this study is twofold: (1) to study the revalence, determinants and consequences of subclinical noncompliance in a sample of renal transplant recipients with a fonctioning graft more than 1 year posttransplant using electronic event monitoring methodology (EEM). (2) to randomize the effectiveness of an individudalized combined educational/behavioral intervention to improve compliance with immunosuppressive therapy (Randomized Controlled Trial (RCT). The study will be guided by following research questions:
Part I:What is the prevalence of subclinical noncompliance with immunosuppressive therapy in RTX recipients (>1 year posttransplant) as measured by EEM? What are selected derterminants of subclinical noncompliance with immunosuppressive therapy in RTX patients? What is the association between subclinical noncompliance and the prevalence of negative clinical outcome [(i.e. acute rejection(s) in RTX recipients beyond 1 year post-RTX until inclusion in the study (retrospective analysis)}?
Part II: What is the effect of a 3-month indiviualized combined educational/behavioral intervention on compliance with immunosuppressive regimen in subclinical noncompliers? How long does the hypothesized beneficial impact of the compliance intervention last (after completion of the 3-month intervention in the intervention cohort)?
Findings of this study will be disseminated to transplant clinicians at international and national scientific conferences and will be published in the transplant literature. Moreover, if the compliance intervention would prove to be successful, guidelines for clinical transplant practice can be developed and training sessions for transplant clinicians could be organized.<