Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients
Brief Summary: 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.


Options:
A: Arm Label: SystemCHANGE; Type: EXPERIMENTAL; Interventions: Behavioral: SystemCHANGE | Arm Label: Patient-education attention-control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Patient-education attention control | Intervention Type: BEHAVIORAL; Name: SystemCHANGE; Assigned to Arm(s): SystemCHANGE | Intervention Type: BEHAVIORAL; Name: Patient-education attention control; Assigned to Arm(s): Patient-education attention-control
B: Intervention Type: BEHAVIORAL; Name: Mindfulness Based Stress Reduction; Assigned to Arm(s): N/A
C: Arm Label: Multi-component Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Action-focused problem-solving, Device: Electronic pillbox monitoring, dose reminders, and feedback | Arm Label: Attention control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Action-focused problem-solving; Assigned to Arm(s): Multi-component Intervention | Intervention Type: DEVICE; Name: Electronic pillbox monitoring, dose reminders, and feedback; Assigned to Arm(s): Multi-component Intervention
D: Arm Label: Group Based; Type: EXPERIMENTAL; Interventions: Behavioral: Group-Based (GB) Intervention | Arm Label: Home-Based; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Home-Based (HB) Intervention | Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Group-Based (GB) Intervention; Assigned to Arm(s): Group Based | Intervention Type: BEHAVIORAL; Name: Home-Based (HB) Intervention; Assigned to Arm(s): Home-Based

Answer: A