Lack of adherence to immunosuppressive therapy following kidney transplantation is a serious public health issue, as it is a major contributor to organ loss in this increasingly prevalent medical condition. The major goals of this proposal are to test unannounced phone pill counts as a reliable and valid method of measuring immunosuppressive medication adherence and to test a behavioral intervention designed to improve medication adherence in kidney transplant patients. The study will take place at Downstate Medical Center in Brooklyn. For the assessment phase of the study, subjects will receive an unannounced phone call and be asked to count their immunosuppressive medication pills on the phone with the interviewer. Five more phone visits will take place, with a goal of having subjects receiving a phone call approximately every 2 weeks for 3 months. Subjects whose baseline levels of adherence are less than ideal (below 98%) will be recruited to participate in the second phase of the study, the behavioral intervention. The intervention will be 8 sessions over no more than 12 weeks. The intervention will have sessions devoted to psychoeducation, motivational interviewing, identifying adherence barriers, self monitoring, coping with side effects, develop medication taking strategy, developing support resources, identifying negative affect, behavioral activation, cognitive restructuring, relapse prevention, and planning for the future. Participants who successfully complete the intervention will then undergo another 3 month assessment period, similar to their pre-intervention assessment. This study utilizes a multiple baseline design and will help determine if behavioral intervention is successful at improving medication adherence and immunosupression in kidney transplant patients.
One third of kidney failures are due to medication non-adherence. This study will verify whether unannounced phone pill counts are a reliable and feasible method for immunosuppressive therapy medication adherence in kidney transplant patients and determine if our behavioral intervention is effective at improving medication adherence. This is the first structured trial of a behavioral intervention to improve adherence in this population.
|Cukor, Daniel; Ver Halen, Nisha; Pencille, Melissa et al. (2017) A Pilot Randomized Controlled Trial to Promote Immunosuppressant Adherence in Adult Kidney Transplant Recipients. Nephron 135:6-14|