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:

* Persons \> 21 years of age
* first time recipient of a solitary kidney transplant
* prescribed at least 3 medications for immunosuppression and hypertension
* previous history of non-adherence
* functioning kidney transplant
* ability to speak, hear and understand English
* able to use medication delivery device and self administer medications
* able to operate blood pressure monitor
* comfortable using cell phone
* no other diagnosis that might shorten lifespan
* transplant physician's assent that the patient can participate

Exclusion Criteria:

* failure to meet all inclusion criteria
B: 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
C: Male and female adult patients who are to receive renal transplantation may enter the study. The intention is to enroll 90 patients who have fulfilled inclusion/exclusion criteria into the study. Sixty patients will receive prolonged-release once-daily tacrolimus based therapy; the other thirty patients will receive standard twice-daily tacrolimus based therapy.

Inclusion criteria

* Male or female patients at 20-65 years of age undergoing renal transplantation
* Patients who have been informed of the potential risks and side effects of the study
* Female patients of childbearing potential must agree to maintain effective birth control during the study.
* Patients have been fully informed and have given written informed consent to participate in the study

Exclusion criteria

* Donor age greater than 65 years
* Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)
* Patients who are recipients of multiple solid organ transplants
* Patients undergoing second or subsequent transplantation
* Patients with pre-transplant PRA \> 20%
* Patients with ABO incompatibility or positive lymphocytotoxicity
* Patients with severe, active infection
* Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or total bilirubin \>3 times the upper normal limit
* Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive
* Patients who have been treated with an investigational drug or therapy within one month prior to entry or who will be so treated within 6 months of transplantation
* Patients with a history of malignancy within the last five years except excised squamous or basal cell carcinoma
* Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to comply fully with the study requirements.
* Patients who require on-going dosing with a systemic immunosuppressive drugs prior to transplantation.
* Pregnant woman or breast-feeding mother during the period of this study.
* Patients who are allergy to tacrolimus, macrolide antibiotics, steroid or mycophenolate mofetil.
D: Inclusion Criteria:

* all eligible patients with follow-up at our outpatient clinic
* written informed consent
* sufficient German language skills to read and answer a battery of questionnaires
* \> 18 years
* minimum 6 mts post HTX

Exclusion Criteria:

* illiteracy

Answer: B