JMIR Publications

ABSTRACT

Background:

Despite significant advances in the care of kidney transplant recipients (KTRs), long-term graft survival remains poor. Poor medication adherence (MA) and poor control of comorbid medical conditions, particularly hypertension (HTN), are major risk factors for premature graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have had success in improving sustained MA and blood pressure control among KTRs. We provide a rationale for a RCT evaluating a mobile health technology enabled, user centered, theory guided, medical regimen self-management system for KTRs called Smart phone medication adherence saves kidneys (SMASK). O

Objective:

ur objective is to determine whether the SMASK program compared to an enhanced standard care attention control arm is efficacious in improving MA and sustaining BP control among KTRs with uncontrolled HTN and poor MA.

Methods:

This two-arm six-month phase II single site efficacy RCT will involve 80 KTRs. They will be randomly assigned to the SMASK intervention arm or the control arm. The SMASK program includes multi-level components: 1) automated reminders from an electronic medication tray; 2) tailored text message motivational feedback and reinforcement guided by self-determination theory and based upon adherence to daily medication and BP monitoring and 3) automated summary reports and direct alerts to providers. Evaluations will occur at pre-intervention, months 3 and 6, and post-trial follow-ups at month 12.

Results:

Specific aims are to test the hypotheses that, compared to the SC cohort, the SMASK cohort will demonstrate significantly improved and sustained changes at months 3, 6 and 12 in: 1) Primary Outcome Variables: a) Medication adherence: % with electronic monitor-derived es >0.90; b) BP control: % reaching and sustaining KDIGO guidelines for BP control (clinic resting BP <130/80 mmHg). 2) Secondary Outcome Variables: a) Provider adherence to KDIGO guidelines as measured by timing of medication changes; b) Changes in Self-Determination Theory constructs (e.g., competence and autonomous regulation). 3) Exploratory Outcome Variables: a) Estimated glomerular filtration rate; b) Variability in calcineurin inhibitor trough levels; c) % reaching and sustaining 24-hr ambulatory BP<130/80 mmHg. After 6-month trial completion evaluation, interviews with random sample of SMASK subjects (n=20) and healthcare providers (3-5) will assess key user reactions including acceptability, usability, salience and aids/barriers to sustainability.intervention, months 3 and 6, and post-trial follow-ups at month 12.

Conclusions:

Data from RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multi-site effectiveness RCT. Clinical Trial: ClinicalTrials.gov Identifier NCT02827695, Register 11 July 2016, https://clinicaltrials.gov/ct2/show/NCT02827695?term=mcgillicuddy&rank=2