Please select the eligibility criteria that correspond to the clinical trial below.
Title: SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients
Brief Summary: With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.


Options:
A: Inclusion Criteria:

1. age 18 years or older,
2. prescribed at least 1 immunosuppressive medication taken twice a day,
3. functioning KT (not on dialysis),
4. has received a kidney-only transplant,
5. agreement from the transplant physician and nephrologist that individual is able to participate in the study,
6. able to speak, hear, and understand English as determined by the ability to participate and comprehend conversation about potential inclusion in the study,
7. able to open a MEMS cap as assessed by the Research Assistant (RA) asking if there is any problem with opening pill bottle caps,
8. able to administer immunosuppressive medications to self,
9. has a telephone or has access to a telephone,
10. has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam,
11. has no other diagnoses that may shorten life span, such as metastatic cancer,
12. is not currently hospitalized,
13. receives post-transplant care by the Missouri or Tennessee transplant programs.

Exclusion Criteria:

* None
B: Inclusion Criteria:

* Diabetes Type 2
* Albuminuria
* Age 30-70

Exclusion Criteria:

* Diabetes duration \< 3 years
* Preexisting non-diabetic kidney
* Psychiatric disorders
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
C: Inclusion Criteria:

* Subjects age 11 - 24 years
* At least 3 months post kidney transplant

Exclusion Criteria:

* Significant neurocognitive disabilities limiting the subject's ability to understand and participate on their own
* Unable to communicate in English or French (Montreal site)
* Unable to communicate in English (all other sites)
D: Inclusion Criteria:

* African American race
* male or female
* 21 to 80 years old
* diagnosis of ESRD
* eligible for listing on the kidney transplant waiting list at Beth Israel Deaconess Medical Center
* resides within 150 minutes of transplant center
* residential or cell phone service
* signed informed consent

Exclusion Criteria:

* Wait-listed for additional organ transplant (i.e., heart, liver)
* current substance abuse or dependency
* known or suspected psychotic disorder
* known or suspected mental retardation

Answer: A