title: MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients.
abstract: Among adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trial
  
  
  
  We report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are <85 % adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined.
  
  
  
  Based on the large effect size of 1.4 found in our pilot study, intervention shows great promise for increasing adherence. Grounded in the socio-ecological model, SystemCHANGE™ seeks to systematically improve medication adherence 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. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating differences between the two groups at the end of the 6-and 12- month phases. Mediators and moderators of medication adherence will be examined. Patient outcomes will be compared and a cost-effectiveness analysis will be conducted.
  
  
  
  ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.
authors.affiliation: School of Nursing and Health Studies, University of Missouri-Kansas City, Health Sciences Building 2407, Kansas City, MO, 64108, USA. RussellC@umkc.edu.
authors.forename: Cynthia L
authors.initials: CL
authors.lastname: Russell
authors.affiliation: Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH, 44106, USA.
authors.forename: Shirley
authors.initials: S
authors.lastname: Moore
authors.affiliation: Department of Advanced Practice and Doctoral Studies, 920 Madison, #924, Memphis, TN, 38163, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Hathaway
authors.affiliation: School of Nursing and Health Studies, University of Missouri-Kansas City, Health Sciences Building 2407, Kansas City, MO, 64108, USA.
authors.forename: An-Lin
authors.initials: AL
authors.lastname: Cheng
authors.affiliation: Department of Internal Medicine, University of Kansas Medical Center, 4043 Wescoe, MS 1037 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
authors.forename: Guoqing
authors.initials: G
authors.lastname: Chen
authors.affiliation: Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, University of Missouri - Kansas City Schools of Medicine and Pharmacy, 2401 Gillham Road, Kansas City, MO, 64108, USA.
authors.forename: Kathy
authors.initials: K
authors.lastname: Goggin
mesh_terms: D000328:Adult; D032763:Behavior Control / Q000379:methods*; D003362:Cost-Benefit Analysis; D005246:Feedback; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation; D055118:Medication Adherence; D012107:Research Design; D012944:Social Support
chemical_list: D007166:Immunosuppressive Agents
keywords: Adherence; Cost-effectiveness; Outcomes; Randomized controlled trial; Transplantation