SystemCHANGE: An Intervention for Medication Change in Adult Kidney Transplant Patients
Status unconfirmed · Phase 3
Conditions studied: Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT02416479
- Run by
- Cynthia Russell
- People needed
- 84
- Starts
- 2014-06-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2018-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 18 years or older,
- prescribed at least 1 immunosuppressive medication taken twice a day,
- functioning KT (not on dialysis),
- has received a kidney-only transplant,
- agreement from the transplant physician and nephrologist that individual is able to participate in the study,
- able to speak, hear, and understand English as determined by the ability to participate and comprehend conversation about potential inclusion in the study,
- able to open a MEMS cap as assessed by the Research Assistant (RA) asking if there is any problem with opening pill bottle caps,
- able to administer immunosuppressive medications to self,
- has a telephone or has access to a telephone,
- 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,
- has no other diagnoses that may shorten life span, such as metastatic cancer,
- is not currently hospitalized,
- receives post-transplant care by the Missouri or Tennessee transplant programs.
You may not qualify if…
- None
Where it is running
- University of Missouri-Kansas City — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.