Kidney Transplantation
Conditions
Keywords
Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring
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.
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.
Interventions
BEHAVIORALIntensive telephone followup
Telephone calling
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Kidney transplant * Discharged from hospital with functioning graft
Exclusion criteria
* Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome * Patients with active psychosis * Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge * Patients taking the liquid form of azathioprine or mycophenolate mofetil * Patients who are younger than 14 yrs. old * Patients who do not speak English * Receiving extra-renal organ except for pancreas,either simultaneously or previously * Patients who live and will be followed outside of the United States, except Canada * Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap * Patients who are not responsible for taking their own medications, e.g. living in a medical care facility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft loss | prospective |
Secondary
| Measure | Time frame |
|---|---|
| Acute rejection | prospective |
| Death | prospective |
Countries
United States
Outcome results
None listed