Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Jul 16;17(1):84.
doi: 10.1186/s12882-016-0285-8.

MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients

Cynthia L Russell  1 , Shirley Moore  2 , Donna Hathaway  3 , An-Lin Cheng  4 , Guoqing Chen  5 , Kathy Goggin  6
Affiliations
Randomized Controlled Trial

MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients

Cynthia L Russell et al. BMC Nephrol. .

Abstract

Background: 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

Methods/design: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.

Keywords: Adherence; Cost-effectiveness; Outcomes; Randomized controlled trial; Transplantation.

PubMed Disclaimer

References

    1. De Geest S, Borgermans L, Gemoets H, et al. Incidence, determinants, and consequences of subclinical noncompliance with immunosuppressive therapy in renal transplant recipients. Transplantation. 1995;59(3):340–47. doi: 10.1097/00007890-199502000-00006. - DOI - PubMed
    1. Hong JH, Sumrani N, Delaney V, et al. Causes of late renal allograft failure in the ciclosporin era. Nephron. 1992;62(3):272–79. doi: 10.1159/000187058. - DOI - PubMed
    1. Nevins TE, Kruse L, Skeans MA, et al. The natural history of azathioprine compliance after renal transplantation. Kidney Int. 2001;60(4):1565–70. doi: 10.1046/j.1523-1755.2001.00961.x. - DOI - PubMed
    1. Shoskes DA, Avelino L, Barba L, et al. Patient death or renal graft loss within 3 yr of transplantation in a county hospital: Importance of poor initial graft function. Clin Transpl. 1997;11(6):618–22. - PubMed
    1. Douglas S, Blixen C, Bartucci R. Relationship between pretransplant noncompliance and posttransplant outcomes in renal transplant recipients. J Transpl Coord. 1996;6(2):53–8. doi: 10.7182/prtr.1.6.2.x11r325882657x21. - DOI - PubMed

Publication types

Substances

Associated data