Predictors and Intervention for Noncompliance
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 14 - Any |
| Updated: | 7/11/2015 |
| Start Date: | August 1998 |
| End Date: | August 2013 |
| Contact: | Thomas E Nevins, MD |
| Email: | nevin001@umn.edu |
| Phone: | 612-626-2922 |
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.
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.
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.
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
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