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Smart Phone Medication Adherence Saves Kidneys--SMASK

NCT02827695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-10-22

No results posted yet for this study

Summary

Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.

Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.

Conditions

Interventions

BEHAVIORAL

SMASK

Medication adherence and BP monitoring

BEHAVIORAL

EnhancedSC

Standard care without med reminder functions with healthy lifestyle texts

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • John McGillicuddy, MD · MUSC Transplant Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2020-05-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02827695 on ClinicalTrials.gov