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:

* 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)
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: Inclusion Criteria:

1. Men and women aged 19 and over
2. At least 1 month lapsing from kidney transplantation
3. Stable renal function maintained after kidney transplantation(eGFR ≥ 30 mL/min/1.73m2)
4. History of kidney transplantation only and no other organs
5. Use of tacrolimus, mycophenolic acid, and steroids for post-transplant immunosuppression
6. Patients, with capability and willingness to give consent to trial participation, who have signed the informed consent form in compliance with due process and are capable of making office visits and taking part in the trial as required by the protocol.

Exclusion Criteria:

1. Patients' refusal of the ICT-based centralized home monitoring
2. History of treatment for acute rejection within the past 3 months
3. Active infectious disease
4. Uncorrected ischemic heart disease
5. Visual or auditory defects that could affect use of the smart pill box
6. Fingerprint authentication of personal identity deemed impossible (ex: adermatoglyphia)
7. Other reasons determined by investigators that make participation in the clinical trial inappropriate
D: 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

Answer: B