MAGIC Study: Aims, Design and Methods using SystemCHANGETM to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients.
Russell CL, Moore S, et al.BMC Nephrology 2016; 17(1): 84.
Aims
This study aims to determine whether the `SystemCHANGE’ intervention is more effective than the attention-control intervention in improving medication adherence in adult kidney transplant recipients. This study also examines patterns of medication adherence.
Interventions
Participants will be randomized into a 6-month SystemCHANGE intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention.
Participants
Adult kidney transplant patients at any time point since their transplant. PartIcipants will be included in the study if they are prescribed at least one immunosuppressive medication and have a kidney-only transplant or kidney re-transplant.
Outcomes
The primary outcome is medication adherence measured by the ‘Medication Event Monitoring System SmartCap’. Additional outcomes include blood creatinine, blood urea nitrogen (BUN) level acute and chronic rejection, infection, health-related quality of life and mortality.
Follow-up
12 months
CET Conclusions
This RCT protocol paper describes the investigation of the efficacy of the SystemCHANGE intervention in terms of adherence in adult kidney transplant recipients. The secondary aim is to examine the patterns of medication adherence. The study will study mediators and moderators of adherence and explore efficacy in terms of health outcomes and cost-effectiveness. During an initial screening phase of 3 months (n=190) electronic drug monitoring will be used to determine which patients are non-adherent (medical adherence ≤85%). Non-adherent patient patients will be randomised according to a computer-generated list of random numbers to the SystemCHANGE intervention or the attention control intervention. Randomisation will be stratified according to low (<70% adherence) and moderate non-adherence (70-84% adherence) and allocation will be concealed for study personnel. The intervention is based on the Socio-Ecological Model and focuses on redesigning the system of the individual interpersonal environment and daily routines related to health behaviour. During the 6-month intervention participants will receive a home visit at baseline plus six monthly telephone calls. The control group receives education guided by healthy-living patient educational materials. Specially trained research assistants with a research nursing background will deliver the interventions. Outcomes will be measured immediately after the intervention at 6 months and again at 12 months. The study duration is described as 4 years which is quite long and the study needs 45 patients per study arm to provide 90% power. Patients will be blinded but no further description of blinding is provided.
Quality notes
Quality assessment not appropriate
Trial registration
ClinicalTrials.gov - NCT02416479